Trial Outcomes & Findings for Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19 (NCT NCT04426695)

NCT ID: NCT04426695

Last Updated: 2023-01-27

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 2252 participants
• Primary outcome timeframe: Day 1 to Day 7
• Results posted on: 2023-01-27

Participant Flow

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.

Participant milestones

Measure	Phase 1: Cohort 1 (Placebo) 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 1 (Cohort 1).	Phase 1: Cohort 1 (R10933+R10987 2400 mg IV) 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).	Phase 1: Cohort 1 (R10933+R10987 8000 mg IV) 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).	Phase 2: Cohort 1 (Placebo) 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 2 (Cohort 1)	Phase 2: Cohort 1 (R10933+R10987 2400 mg 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 2 (Cohort 1)	Phase 2: Cohort 1 (R10933+R10987 8000 mg IV) 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 2 (Cohort 1)	Phase 3: Cohort 1 (Placebo) 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)	Phase 3: Cohort 1 (R10933+R10987 2400 mg) 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 3 (Cohort 1)	Phase 3: Cohort 1 (R10933+R10987 8000 mg IV) 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)	Phase 2: Cohort 1A (Placebo) 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).	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 Phase 2 (Cohort 1A).	Phase 2: Cohort 1A (R10933+R10987 8000 mg IV) 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).	Phase 2: Cohort 2 (Placebo) 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).	Phase 2: Cohort 2 (R10933+R10987 2400 mg IV) 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).	Phase 2: Cohort 2 (R10933+R10987 8000 mg IV) 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).	Phase 2: Cohort 3 (Placebo) Participants on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2: Cohort 3 (R10933+R10987 2400 mg IV) Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2: Cohort 3 (R10933+R10987 8000 mg IV) Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).
Overall Study STARTED	21	19	20	208	211	210	251	252	252	201	205	203	52	58	54	12	12	11
Overall Study Treated	18	18	20	204	206	205	247	246	246	198	202	197	51	56	54	12	12	11
Overall Study COMPLETED	13	12	16	146	153	148	186	195	189	157	165	166	33	28	31	5	4	7
Overall Study NOT COMPLETED	8	7	4	62	58	62	65	57	63	44	40	37	19	30	23	7	8	4

Reasons for withdrawal

Measure	Phase 1: Cohort 1 (Placebo) 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 1 (Cohort 1).	Phase 1: Cohort 1 (R10933+R10987 2400 mg IV) 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).	Phase 1: Cohort 1 (R10933+R10987 8000 mg IV) 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).	Phase 2: Cohort 1 (Placebo) 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 2 (Cohort 1)	Phase 2: Cohort 1 (R10933+R10987 2400 mg 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 2 (Cohort 1)	Phase 2: Cohort 1 (R10933+R10987 8000 mg IV) 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 2 (Cohort 1)	Phase 3: Cohort 1 (Placebo) 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)	Phase 3: Cohort 1 (R10933+R10987 2400 mg) 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 3 (Cohort 1)	Phase 3: Cohort 1 (R10933+R10987 8000 mg IV) 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)	Phase 2: Cohort 1A (Placebo) 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).	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 Phase 2 (Cohort 1A).	Phase 2: Cohort 1A (R10933+R10987 8000 mg IV) 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).	Phase 2: Cohort 2 (Placebo) 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).	Phase 2: Cohort 2 (R10933+R10987 2400 mg IV) 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).	Phase 2: Cohort 2 (R10933+R10987 8000 mg IV) 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).	Phase 2: Cohort 3 (Placebo) Participants on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2: Cohort 3 (R10933+R10987 2400 mg IV) Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2: Cohort 3 (R10933+R10987 8000 mg IV) Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).
Overall Study Death	2	0	1	27	25	21	42	23	37	14	8	7	13	25	19	7	8	4
Overall Study Lost to Follow-up	2	4	1	19	10	14	5	14	10	11	12	6	2	2	2	0	0	0
Overall Study Participant Decision	1	2	2	12	18	22	13	13	10	15	16	17	2	1	2	0	0	0
Overall Study Adverse Event	0	0	0	0	0	0	0	1	0	0	1	1	0	0	0	0	0	0
Overall Study Sponsor Request	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Overall Study Physician Decision	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0
Overall Study Randomized but Never Treated	3	1	0	4	5	5	4	6	6	3	3	6	1	2	0	0	0	0

Baseline Characteristics

Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19

Baseline characteristics by cohort

Measure	Phase 1: Cohort 1 (Placebo) n=18 Participants 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 1 (Cohort 1)	Phase 1: Cohort 1 (R10933+R10987 2400 mg IV) n=18 Participants 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 1 (Cohort 1)	Phase 1: Cohort 1 (R10933+R10987 8000 mg IV) n=20 Participants 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)	Phase 2: Cohort 1 (Placebo) n=204 Participants 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 2 (Cohort 1)	Phase 2: Cohort 1 (R10933+R10987 2400 mg IV) n=206 Participants 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)	Phase 2: Cohort 1 (R10933+R10987 8000 mg IV) n=205 Participants 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 2 (Cohort 1)	Phase 3: Cohort 1 (Placebo) n=247 Participants 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).	Phase 3: Cohort 1 (R10933+R10987 2400 mg IV) n=246 Participants Phase 1: Cohort 1 (R10933+R10987 2400 mg IV)Edit 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.	Phase 3: Cohort 1 (R10933+R10987 8000 mg IV) n=246 Participants 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)	Phase 2: Cohort 1A (Placebo) n=198 Participants 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).	Phase 2: Cohort 1A (R10933+R10987 2400 mg IV) n=202 Participants 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).	Phase 2: Cohort 1A (R10933+R10987 8000 mg IV) n=197 Participants 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).	Phase 2: Cohort 2 (Placebo) n=51 Participants 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).	Phase 2: Cohort 2 (R10933+R10987 2400 mg IV) n=56 Participants 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).	Phase 2: Cohort 2 (R10933+R10987 8000 mg IV) n=54 Participants 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).	Phase 2: Cohort 3 (Placebo) n=12 Participants Participants on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2: Cohort 3 (R10933+R10987 2400 mg IV) n=12 Participants Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2: Cohort 3 (R10933+R10987 8000 mg IV) n=11 Participants Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Total n=2203 Participants Total of all reporting groups
Age, Customized Age: 18- <40 years	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	26 Participants n=483 Participants	16 Participants n=36 Participants	17 Participants n=10 Participants	29 Participants n=115 Participants	28 Participants n=40 Participants	14 Participants n=8 Participants	22 Participants n=62 Participants	20 Participants n=95 Participants	20 Participants n=129 Participants	4 Participants n=36 Participants	4 Participants n=36 Participants	6 Participants n=24 Participants	0 Participants n=135 Participants	1 Participants n=136 Participants	1 Participants n=44 Participants	212 Participants n=667 Participants
Age, Customized Age: 40- <65 years	9 Participants n=93 Participants	8 Participants n=4 Participants	10 Participants n=27 Participants	82 Participants n=483 Participants	99 Participants n=36 Participants	96 Participants n=10 Participants	105 Participants n=115 Participants	119 Participants n=40 Participants	127 Participants n=8 Participants	82 Participants n=62 Participants	101 Participants n=95 Participants	91 Participants n=129 Participants	30 Participants n=36 Participants	23 Participants n=36 Participants	24 Participants n=24 Participants	6 Participants n=135 Participants	4 Participants n=136 Participants	5 Participants n=44 Participants	1021 Participants n=667 Participants
Age, Customized Age: >=65 years	8 Participants n=93 Participants	9 Participants n=4 Participants	8 Participants n=27 Participants	96 Participants n=483 Participants	91 Participants n=36 Participants	92 Participants n=10 Participants	113 Participants n=115 Participants	99 Participants n=40 Participants	105 Participants n=8 Participants	94 Participants n=62 Participants	81 Participants n=95 Participants	86 Participants n=129 Participants	17 Participants n=36 Participants	29 Participants n=36 Participants	24 Participants n=24 Participants	6 Participants n=135 Participants	7 Participants n=136 Participants	5 Participants n=44 Participants	970 Participants n=667 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	8 Participants n=4 Participants	10 Participants n=27 Participants	90 Participants n=483 Participants	98 Participants n=36 Participants	98 Participants n=10 Participants	113 Participants n=115 Participants	112 Participants n=40 Participants	115 Participants n=8 Participants	91 Participants n=62 Participants	87 Participants n=95 Participants	89 Participants n=129 Participants	17 Participants n=36 Participants	20 Participants n=36 Participants	20 Participants n=24 Participants	8 Participants n=135 Participants	4 Participants n=136 Participants	2 Participants n=44 Participants	990 Participants n=667 Participants
Sex: Female, Male Male	10 Participants n=93 Participants	10 Participants n=4 Participants	10 Participants n=27 Participants	114 Participants n=483 Participants	108 Participants n=36 Participants	107 Participants n=10 Participants	134 Participants n=115 Participants	134 Participants n=40 Participants	131 Participants n=8 Participants	107 Participants n=62 Participants	115 Participants n=95 Participants	108 Participants n=129 Participants	34 Participants n=36 Participants	36 Participants n=36 Participants	34 Participants n=24 Participants	4 Participants n=135 Participants	8 Participants n=136 Participants	9 Participants n=44 Participants	1213 Participants n=667 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=93 Participants	7 Participants n=4 Participants	10 Participants n=27 Participants	49 Participants n=483 Participants	50 Participants n=36 Participants	52 Participants n=10 Participants	92 Participants n=115 Participants	94 Participants n=40 Participants	82 Participants n=8 Participants	38 Participants n=62 Participants	53 Participants n=95 Participants	40 Participants n=129 Participants	13 Participants n=36 Participants	22 Participants n=36 Participants	18 Participants n=24 Participants	6 Participants n=135 Participants	5 Participants n=136 Participants	4 Participants n=44 Participants	647 Participants n=667 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=93 Participants	11 Participants n=4 Participants	10 Participants n=27 Participants	144 Participants n=483 Participants	148 Participants n=36 Participants	146 Participants n=10 Participants	146 Participants n=115 Participants	140 Participants n=40 Participants	155 Participants n=8 Participants	148 Participants n=62 Participants	138 Participants n=95 Participants	143 Participants n=129 Participants	35 Participants n=36 Participants	33 Participants n=36 Participants	30 Participants n=24 Participants	6 Participants n=135 Participants	7 Participants n=136 Participants	7 Participants n=44 Participants	1453 Participants n=667 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	11 Participants n=483 Participants	8 Participants n=36 Participants	7 Participants n=10 Participants	9 Participants n=115 Participants	12 Participants n=40 Participants	9 Participants n=8 Participants	12 Participants n=62 Participants	11 Participants n=95 Participants	14 Participants n=129 Participants	3 Participants n=36 Participants	1 Participants n=36 Participants	6 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	103 Participants n=667 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	1 Participants n=36 Participants	2 Participants n=10 Participants	9 Participants n=115 Participants	9 Participants n=40 Participants	13 Participants n=8 Participants	0 Participants n=62 Participants	0 Participants n=95 Participants	0 Participants n=129 Participants	1 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	36 Participants n=667 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	2 Participants n=4 Participants	0 Participants n=27 Participants	6 Participants n=483 Participants	7 Participants n=36 Participants	6 Participants n=10 Participants	6 Participants n=115 Participants	10 Participants n=40 Participants	9 Participants n=8 Participants	11 Participants n=62 Participants	8 Participants n=95 Participants	6 Participants n=129 Participants	2 Participants n=36 Participants	2 Participants n=36 Participants	1 Participants n=24 Participants	1 Participants n=135 Participants	1 Participants n=136 Participants	0 Participants n=44 Participants	78 Participants n=667 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants	1 Participants n=36 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=40 Participants	1 Participants n=8 Participants	0 Participants n=62 Participants	0 Participants n=95 Participants	1 Participants n=129 Participants	1 Participants n=36 Participants	1 Participants n=36 Participants	0 Participants n=24 Participants	1 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	10 Participants n=667 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants	2 Participants n=4 Participants	8 Participants n=27 Participants	34 Participants n=483 Participants	21 Participants n=36 Participants	33 Participants n=10 Participants	26 Participants n=115 Participants	32 Participants n=40 Participants	25 Participants n=8 Participants	27 Participants n=62 Participants	32 Participants n=95 Participants	25 Participants n=129 Participants	7 Participants n=36 Participants	6 Participants n=36 Participants	9 Participants n=24 Participants	1 Participants n=135 Participants	1 Participants n=136 Participants	3 Participants n=44 Participants	295 Participants n=667 Participants
Race (NIH/OMB) White	12 Participants n=93 Participants	11 Participants n=4 Participants	11 Participants n=27 Participants	136 Participants n=483 Participants	146 Participants n=36 Participants	134 Participants n=10 Participants	159 Participants n=115 Participants	151 Participants n=40 Participants	158 Participants n=8 Participants	111 Participants n=62 Participants	116 Participants n=95 Participants	131 Participants n=129 Participants	33 Participants n=36 Participants	39 Participants n=36 Participants	36 Participants n=24 Participants	8 Participants n=135 Participants	9 Participants n=136 Participants	5 Participants n=44 Participants	1406 Participants n=667 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants	0 Participants n=62 Participants	0 Participants n=95 Participants	0 Participants n=129 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants	3 Participants n=4 Participants	1 Participants n=27 Participants	25 Participants n=483 Participants	30 Participants n=36 Participants	29 Participants n=10 Participants	47 Participants n=115 Participants	43 Participants n=40 Participants	40 Participants n=8 Participants	49 Participants n=62 Participants	46 Participants n=95 Participants	34 Participants n=129 Participants	7 Participants n=36 Participants	8 Participants n=36 Participants	8 Participants n=24 Participants	1 Participants n=135 Participants	1 Participants n=136 Participants	3 Participants n=44 Participants	378 Participants n=667 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 7

Population: The seronegative modified full analysis set (mFAS) was defined as all participants in mFAS with documented seronegative status at the baseline. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=160 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=310 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=131 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=150 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	-1.34 log10 copies/milliliter (mL) Standard Error 0.09	-1.31 log10 copies/milliliter (mL) Standard Error 0.06	-1.03 log10 copies/milliliter (mL) Standard Error 0.10	-1.28 log10 copies/milliliter (mL) Standard Error 0.09	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 6 to Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\>) 10\^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for 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 were reported.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=225 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=445 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=211 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=220 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	12.4 Percentage of Participants Interval 8.4 to 17.5	9.9 Percentage of Participants Interval 7.3 to 13.0	13.3 Percentage of Participants Interval 9.0 to 18.6	7.3 Percentage of Participants Interval 4.2 to 11.5	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 6 to Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for 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 were reported.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=179 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=341 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=147 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=162 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	10.6 Percentage of Participants Interval 6.5 to 16.1	7.9 Percentage of Participants Interval 5.3 to 11.3	15.0 Percentage of Participants Interval 9.6 to 21.8	4.9 Percentage of Participants Interval 2.2 to 9.5	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 6 to Day 29

Population: The mFAS included all FAS participants with a positive SARS-CoV-2 RT-qPCR conducted in the central laboratory in NP swab samples at randomization. Analysis based on treatment allocated (as randomized). "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.

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

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=383 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=770 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=367 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=387 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	10.7 Percentage of Participants Interval 7.8 to 14.2	8.1 Percentage of Participants Interval 6.2 to 10.2	10.6 Percentage of Participants Interval 7.7 to 14.2	5.4 Percentage of Participants Interval 3.4 to 8.2	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 to Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load \> 10\^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for 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 were reported.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=236 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=467 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=229 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=231 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	14.4 Percentage of Participants Interval 10.2 to 19.5	12.2 Percentage of Participants Interval 9.4 to 15.5	18.8 Percentage of Participants Interval 13.9 to 24.4	10.0 Percentage of Participants Interval 6.4 to 14.6	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 to Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for 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 were reported.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=188 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=360 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=160 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=172 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	12.2 Percentage of Participants Interval 7.9 to 17.8	10.3 Percentage of Participants Interval 7.3 to 13.9	19.4 Percentage of Participants Interval 13.6 to 26.4	8.1 Percentage of Participants Interval 4.5 to 13.3	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 to Day 29

Population: The mFAS included all FAS participants with a positive SARS-CoV-2 RT-qPCR conducted in the central laboratory in NP swab samples at randomization. Analysis based on treatment allocated (as randomized). "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.

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

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=398 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=804 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=393 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=406 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	12.6 Percentage of Participants Interval 9.5 to 16.2	10.2 Percentage of Participants Interval 8.2 to 12.5	14.8 Percentage of Participants Interval 11.4 to 18.7	7.9 Percentage of Participants Interval 5.5 to 10.9	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 169

Population: The mFAS included all FAS participants with a positive SARS-CoV-2 RT-qPCR conducted in the central laboratory in NP swab samples at randomization. Analysis based on treatment allocated (as randomized). "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=225 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=449 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=222 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=224 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Treatment-Emergent Serious Adverse Events	47 Participants	92 Participants	54 Participants	45 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 4

Population: The mFAS included all FAS participants with a positive SARS-CoV-2 RT-qPCR conducted in the central laboratory in NP swab samples at randomization. Analysis based on treatment allocated (as randomized). "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.

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).

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=225 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=449 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=222 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=224 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4	6 Participants	8 Participants	3 Participants	2 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 29

Population: The mFAS included all FAS participants with a positive SARS-CoV-2 RT-qPCR conducted in the central laboratory in NP swab samples at randomization. Analysis based on treatment allocated (as randomized). "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=225 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=449 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=222 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=224 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29	2 Participants	4 Participants	1 Participants	2 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 29

Population: Seronegative modified full analysis set (mFAS) was defined as all participants in mFAS with documented seronegative status at the baseline. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 1 \[Cohort 1\] and Phase 2 \[Cohort 1\].

Cumulative incidence percentage was estimated using Kaplan-Meier method.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=41 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=87 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=32 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=46 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on Seronegative mFAS	20.3 Cumulative Incidence Percentage Interval 14.7 to 27.8	17.6 Cumulative Incidence Percentage Interval 13.8 to 22.3	23.0 Cumulative Incidence Percentage Interval 16.9 to 30.9	15.1 Cumulative Incidence Percentage Interval 10.5 to 21.4	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 29

Population: High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\>) 10\^6 copies per milliliter (mL). As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 1 \[Cohort 1\] and Phase 2 \[Cohort 1\].

Cumulative incidence percentage was estimated using Kaplan-Meier method.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=58 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=111 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=50 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=53 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on High Viral Load mFAS	11.6 Cumulative Incidence Percentage Interval 8.0 to 16.8	15.3 Cumulative Incidence Percentage Interval 12.2 to 19.0	20.7 Cumulative Incidence Percentage Interval 15.7 to 26.9	18.9 Cumulative Incidence Percentage Interval 14.3 to 24.8	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: by Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load \> 10\^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for 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 in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=236 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=467 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=229 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=231 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	8.5 Percentage of Participants Interval 5.3 to 12.8	7.3 Percentage of Participants Interval 5.1 to 10.0	11.4 Percentage of Participants Interval 7.6 to 16.2	6.1 Percentage of Participants Interval 3.4 to 10.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: by Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=188 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=360 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=160 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=172 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	7.4 Percentage of Participants Interval 4.1 to 12.2	6.7 Percentage of Participants Interval 4.3 to 9.8	10.0 Percentage of Participants Interval 5.8 to 15.7	5.8 Percentage of Participants Interval 2.8 to 10.4	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 6 to Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load \> 10\^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for 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 were reported.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=228 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=454 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=222 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=226 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	10.1 Percentage of Participants Interval 6.5 to 14.8	8.6 Percentage of Participants Interval 6.2 to 11.6	13.1 Percentage of Participants Interval 8.9 to 18.2	7.1 Percentage of Participants Interval 4.1 to 11.2	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 6 to Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=181 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=348 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=153 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=167 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	7.2 Percentage of Participants Interval 3.9 to 12.0	6.0 Percentage of Participants Interval 3.8 to 9.1	13.7 Percentage of Participants Interval 8.7 to 20.2	4.8 Percentage of Participants Interval 2.1 to 9.2	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 to Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load \> 10\^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for 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 in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=236 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=467 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=229 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=231 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	11.0 Percentage of participants Interval 7.3 to 15.7	9.2 Percentage of participants Interval 6.7 to 12.2	14.4 Percentage of participants Interval 10.1 to 19.6	7.4 Percentage of participants Interval 4.3 to 11.5	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 to Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=188 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=360 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=160 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=172 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	8.0 Percentage of Participants Interval 4.5 to 12.8	6.7 Percentage of Participants Interval 4.3 to 9.8	15.0 Percentage of Participants Interval 9.9 to 21.5	5.2 Percentage of Participants Interval 2.4 to 9.7	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: by Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load \> 10\^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=236 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=467 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=229 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=231 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	86.9 Percentage of Participants Interval 81.9 to 90.9	88.0 Percentage of Participants Interval 84.7 to 90.8	80.3 Percentage of Participants Interval 74.6 to 85.3	89.2 Percentage of Participants Interval 84.4 to 92.9	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: by Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=188 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=360 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=160 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=172 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS	89.9 Percentage of Participants Interval 84.7 to 93.8	90.0 Percentage of Participants Interval 86.4 to 92.9	81.3 Percentage of Participants Interval 74.3 to 87.0	90.1 Percentage of Participants Interval 84.6 to 94.1	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load \> 10\^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for 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 in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A)were reported. Readmission to hospital was based on investigator report.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=236 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=467 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=229 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=231 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	17.4 Percentage of Participants Interval 12.8 to 22.8	16.3 Percentage of Participants Interval 13.0 to 19.9	21.0 Percentage of Participants Interval 15.9 to 26.8	15.2 Percentage of Participants Interval 10.8 to 20.4	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: by Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=188 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=360 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=160 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=172 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	12.8 Percentage of Participants Interval 8.4 to 18.4	12.2 Percentage of Participants Interval 9.0 to 16.1	24.4 Percentage of Participants Interval 17.9 to 31.8	11.6 Percentage of Participants Interval 7.2 to 17.4	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: by Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load \> 10\^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=190 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=391 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=181 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=201 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	11.7 Cumulative Incidence Percentage Interval 8.1 to 16.7	9.7 Cumulative Incidence Percentage Interval 7.3 to 12.9	14.9 Cumulative Incidence Percentage Interval 10.8 to 20.3	7.7 Cumulative Incidence Percentage Interval 4.8 to 12.1	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: by Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=160 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=308 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=121 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=148 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	8.4 Cumulative Incidence Percentage Interval 5.1 to 13.5	7.0 Cumulative Incidence Percentage Interval 4.8 to 10.3	15.8 Cumulative Incidence Percentage Interval 10.9 to 22.7	5.6 Cumulative Incidence Percentage Interval 3.0 to 10.5	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: by Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load \> 10\^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=183 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=377 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=170 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=194 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	9.1 Cumulative Incidence Percentage Interval 6.0 to 13.8	7.7 Cumulative Incidence Percentage Interval 5.5 to 10.6	11.8 Cumulative Incidence Percentage Interval 8.2 to 16.8	6.3 Cumulative Incidence Percentage Interval 3.7 to 10.3	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: by Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=152 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=295 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=114 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=143 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS	7.9 Cumulative Incidence Percentage Interval 4.8 to 13.0	7.0 Cumulative Incidence Percentage Interval 4.8 to 10.3	10.6 Cumulative Incidence Percentage Interval 6.6 to 16.8	6.0 Cumulative Incidence Percentage Interval 3.3 to 11.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: by Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load \> 10\^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=183 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=377 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=170 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=194 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	15.0 Cumulative Incidence Percentage Interval 11.0 to 20.4	12.7 Cumulative Incidence Percentage Interval 9.9 to 16.1	19.1 Cumulative Incidence Percentage Interval 14.6 to 24.9	10.2 Cumulative Incidence Percentage Interval 6.9 to 15.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: by Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=152 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=295 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=114 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=143 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	12.7 Cumulative Incidence Percentage Interval 8.7 to 18.6	10.7 Cumulative Incidence Percentage Interval 7.9 to 14.5	20.1 Cumulative Incidence Percentage Interval 14.6 to 27.3	8.4 Cumulative Incidence Percentage Interval 5.1 to 13.8	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 56

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load \> 10\^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=236 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=467 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=229 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=231 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on High Viral Load mFAS	4.0 Days Interval 3.0 to 5.0	4.0 Days Interval 4.0 to 5.0	5.0 Days Interval 4.0 to 6.0	4.0 Days Interval 4.0 to 5.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 56

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=188 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=360 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=160 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=172 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS	4.0 Days Interval 3.0 to 4.0	4.0 Days Interval 3.0 to 4.0	4.5 Days Interval 4.0 to 6.0	4.0 Days Interval 3.0 to 5.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 169

Population: all FAS participants. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=733 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=1473 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=730 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=740 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Treatment-Emergent Serious Adverse Events	181 Participants	358 Participants	203 Participants	177 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 4

Population: all FAS participants. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=733 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=1473 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=730 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=740 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	15 Participants	26 Participants	6 Participants	11 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 29

Population: all FAS participants. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=733 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=1473 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=730 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=740 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	7 Participants	12 Participants	2 Participants	5 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: by Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=82 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=162 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=70 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=80 Participants 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).	Phase 2: Cohort 1A (Placebo) n=90 Participants Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) n=92 Participants 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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) n=106 Participants 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV n=198 Participants 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS	17.1 Percentage of Participants Interval 9.7 to 27.0	13.0 Percentage of Participants Interval 8.2 to 19.1	17.1 Percentage of Participants Interval 9.2 to 28.0	8.8 Percentage of Participants Interval 3.6 to 17.2	4.4 Percentage of Participants Interval 1.2 to 11.0	3.3 Percentage of Participants Interval 0.7 to 9.2	0.0 Percentage of Participants Interval 0.0 to 0.0	1.5 Percentage of Participants Interval 0.3 to 4.4	—	—	—	—

SECONDARY outcome

Timeframe: Day 6 to Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=80 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=159 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=67 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=79 Participants 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).	Phase 2: Cohort 1A (Placebo) n=86 Participants Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) n=88 Participants 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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) n=101 Participants 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV n=189 Participants 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS	10.0 Percentage of Participants Interval 4.4 to 13.6	8.2 Percentage of Participants Interval 4.4 to 13.6	19.4 Percentage of Participants Interval 10.8 to 30.9	6.3 Percentage of Participants Interval 2.1 to 14.2	9.3 Percentage of Participants Interval 4.1 to 17.5	3.4 Percentage of Participants Interval 0.7 to 9.6	5.0 Percentage of Participants Interval 1.6 to 11.2	4.2 Percentage of Participants Interval 1.8 to 8.2	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 to Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=82 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=162 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=70 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=80 Participants 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).	Phase 2: Cohort 1A (Placebo) n=90 Participants Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) n=92 Participants 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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) n=106 Participants 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV n=198 Participants 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS	11.0 Percentage of Participants Interval 5.1 to 19.8	9.3 Percentage of Participants Interval 5.3 to 14.8	22.9 Percentage of Participants Interval 13.7 to 34.4	7.5 Percentage of Participants Interval 2.8 to 15.6	8.9 Percentage of Participants Interval 3.9 to 16.8	3.3 Percentage of Participants Interval 0.7 to 9.2	5.7 Percentage of Participants Interval 2.1 to 11.9	4.5 Percentage of Participants Interval 2.1 to 8.5	—	—	—	—

SECONDARY outcome

Timeframe: by Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=82 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=162 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=70 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=80 Participants 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).	Phase 2: Cohort 1A (Placebo) n=90 Participants Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) n=92 Participants 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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) n=106 Participants 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV n=198 Participants 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS	84.1 Percentage of Participants Interval 74.4 to 91.3	84.6 Percentage of Participants Interval 78.1 to 89.8	70.0 Percentage of Participants Interval 57.9 to 80.4	85.0 Percentage of Participants Interval 75.3 to 92.0	90.0 Percentage of Participants Interval 81.9 to 95.3	94.6 Percentage of Participants Interval 87.8 to 98.2	94.3 Percentage of Participants Interval 88.1 to 97.9	94.4 Percentage of Participants Interval 90.3 to 97.2	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=82 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=162 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=70 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=80 Participants 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).	Phase 2: Cohort 1A (Placebo) n=90 Participants Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) n=92 Participants 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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) n=106 Participants 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV n=198 Participants 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	14.6 Percentage of Participants Interval 7.8 to 24.2	14.2 Percentage of Participants Interval 9.2 to 20.5	27.1 Percentage of Participants Interval 17.2 to 39.1	13.8 Percentage of Participants Interval 7.1 to 23.3	22.2 Percentage of Participants Interval 14.1 to 32.2	9.8 Percentage of Participants Interval 4.6 to 17.8	11.3 Percentage of Participants Interval 6.0 to 18.9	10.6 Percentage of Participants Interval 6.7 to 15.8	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=70 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=140 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=51 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=70 Participants 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).	Phase 2: Cohort 1A (Placebo) n=70 Participants Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) n=78 Participants 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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) n=90 Participants 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV n=168 Participants 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death up to Day 29 Based on Seronegative mFAS	11.4 Cumulative Incidence Percentage Interval 6.1 to 20.7	9.6 Cumulative Incidence Percentage Interval 5.9 to 15.4	23.6 Cumulative Incidence Percentage Interval 15.1 to 35.6	7.8 Cumulative Incidence Percentage Interval 3.6 to 16.5	9.6 Cumulative Incidence Percentage Interval 4.9 to 18.3	3.6 Cumulative Incidence Percentage Interval 1.2 to 10.9	5.9 Cumulative Incidence Percentage Interval 2.7 to 12.8	4.8 Cumulative Incidence Percentage Interval 2.6 to 9.1	—	—	—	—

SECONDARY outcome

Timeframe: by Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=62 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=128 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=46 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=66 Participants 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).	Phase 2: Cohort 1A (Placebo) n=68 Participants Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) n=77 Participants 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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) n=90 Participants 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV n=167 Participants 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS	17.6 Cumulative Incidence Percentage Interval 10.8 to 27.9	13.4 Cumulative Incidence Percentage Interval 8.9 to 19.8	18.2 Cumulative Incidence Percentage Interval 10.8 to 30.0	8.9 Cumulative Incidence Percentage Interval 4.4 to 17.8	4.7 Cumulative Incidence Percentage Interval 1.8 to 12.1	3.5 Cumulative Incidence Percentage Interval 1.1 to 10.5	0.0 Cumulative Incidence Percentage Interval 0.0 to 0.0	1.7 Cumulative Incidence Percentage Interval 0.5 to 5.1	—	—	—	—

SECONDARY outcome

Timeframe: by Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=62 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=128 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=46 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=66 Participants 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).	Phase 2: Cohort 1A (Placebo) n=68 Participants Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) n=77 Participants 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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) n=90 Participants 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV n=167 Participants 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS	21.2 Cumulative Incidence Percentage Interval 13.8 to 31.9	17.0 Cumulative Incidence Percentage Interval 12.0 to 23.8	30.4 Cumulative Incidence Percentage Interval 21.0 to 42.7	12.7 Cumulative Incidence Percentage Interval 7.0 to 22.3	11.8 Cumulative Incidence Percentage Interval 6.5 to 20.8	4.7 Cumulative Incidence Percentage Interval 1.8 to 12.1	5.9 Cumulative Incidence Percentage Interval 2.7 to 12.8	5.4 Cumulative Incidence Percentage Interval 2.9 to 9.7	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 56

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=82 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=162 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=70 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=80 Participants 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).	Phase 2: Cohort 1A (Placebo) n=90 Participants Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) n=86 Participants 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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) n=99 Participants 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV n=198 Participants 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS	6.0 Days Interval 4.0 to 9.0	6.0 Days Interval 4.0 to 7.0	8.5 Days Interval 5.0 to 15.0	5.0 Days Interval 4.0 to 7.0	4.0 Days Interval 3.0 to 4.0	3.0 Days Interval 2.0 to 4.0	3.0 Days Interval 2.0 to 4.0	3.0 Days Interval 2.0 to 4.0	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 to Day 11

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=78 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=154 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=59 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=76 Participants 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).	Phase 2: Cohort 1A (Placebo) n=80 Participants Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) n=79 Participants 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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) n=88 Participants 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV n=167 Participants 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	-1.95 log10 copies/mL Standard Error 0.15	-2.00 log10 copies/mL Standard Error 0.10	-1.52 log10 copies/mL Standard Error 0.17	-2.03 log10 copies/mL Standard Error 0.15	-1.28 log10 copies/mL Standard Error 0.14	-1.88 log10 copies/mL Standard Error 0.14	-2.01 log10 copies/mL Standard Error 0.14	-1.95 log10 copies/mL Standard Error 0.10	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 to Day 29

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=79 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=156 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=64 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=77 Participants 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).	Phase 2: Cohort 1A (Placebo) n=84 Participants Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) n=82 Participants 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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) n=93 Participants 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV n=175 Participants 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 29	-3.69 log10 copies/mL Standard Error 0.20	-3.69 log10 copies/mL Standard Error 0.14	-2.72 log10 copies/mL Standard Error 0.22	-3.68 log10 copies/mL Standard Error 0.20	-2.66 log10 copies/mL Standard Error 0.21	-3.31 log10 copies/mL Standard Error 0.21	-3.58 log10 copies/mL Standard Error 0.20	-3.45 log10 copies/mL Standard Error 0.14	—	—	—	—

SECONDARY outcome

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

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. "Number of Participants Analyzed" = participants with measurements at baseline. "Number Analyzed" = participants with measurements for both baseline and the specific study day. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=82 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=162 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=70 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=80 Participants 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).	Phase 2: Cohort 1A (Placebo) n=90 Participants Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) n=92 Participants 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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) n=106 Participants 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV n=198 Participants 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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 Change at Day 3	-0.93 log10 copies/mL Standard Error 0.19	-0.92 log10 copies/mL Standard Error 0.14	-1.10 log10 copies/mL Standard Error 0.22	-0.90 log10 copies/mL Standard Error 0.19	-0.85 log10 copies/mL Standard Error 0.21	-1.03 log10 copies/mL Standard Error 0.20	-1.41 log10 copies/mL Standard Error 0.19	-1.23 log10 copies/mL Standard Error 0.14	—	—	—	—
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 Change at Day 5	-1.91 log10 copies/mL Standard Error 0.25	-2.11 log10 copies/mL Standard Error 0.17	-1.97 log10 copies/mL Standard Error 0.27	-2.28 log10 copies/mL Standard Error 0.23	-1.55 log10 copies/mL Standard Error 0.25	-2.21 log10 copies/mL Standard Error 0.26	-2.24 log10 copies/mL Standard Error 0.24	-2.21 log10 copies/mL Standard Error 0.18	—	—	—	—
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 Change at Day 7	-3.22 log10 copies/mL Standard Error 0.25	-3.09 log10 copies/mL Standard Error 0.18	-1.97 log10 copies/mL Standard Error 0.30	-2.92 log10 copies/mL Standard Error 0.26	-2.29 log10 copies/mL Standard Error 0.26	-3.06 log10 copies/mL Standard Error 0.25	-3.49 log10 copies/mL Standard Error 0.24	-3.27 log10 copies/mL Standard Error 0.17	—	—	—	—
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 Change at Day 9	-4.16 log10 copies/mL Standard Error 0.27	-4.03 log10 copies/mL Standard Error 0.19	-2.56 log10 copies/mL Standard Error 0.32	-3.89 log10 copies/mL Standard Error 0.27	-2.90 log10 copies/mL Standard Error 0.28	-3.75 log10 copies/mL Standard Error 0.26	-3.85 log10 copies/mL Standard Error 0.24	-3.80 log10 copies/mL Standard Error 0.18	—	—	—	—
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 Change at Day 11	-4.57 log10 copies/mL Standard Error 0.30	-4.41 log10 copies/mL Standard Error 0.21	-3.22 log10 copies/mL Standard Error 0.35	-4.23 log10 copies/mL Standard Error 0.29	-3.88 log10 copies/mL Standard Error 0.32	-4.76 log10 copies/mL Standard Error 0.30	-4.34 log10 copies/mL Standard Error 0.27	-4.52 log10 copies/mL Standard Error 0.2	—	—	—	—
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 Change at Day 13	-5.00 log10 copies/mL Standard Error 0.29	-5.10 log10 copies/mL Standard Error 0.21	-3.76 log10 copies/mL Standard Error 0.35	-5.18 log10 copies/mL Standard Error 0.30	-4.22 log10 copies/mL Standard Error 0.31	-4.56 log10 copies/mL Standard Error 0.29	-5.05 log10 copies/mL Standard Error 0.27	-4.82 log10 copies/mL Standard Error 0.20	—	—	—	—
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 Change at Day 15	-5.25 log10 copies/mL Standard Error 0.27	-5.34 log10 copies/mL Standard Error 0.19	-4.42 log10 copies/mL Standard Error 0.32	-5.41 log10 copies/mL Standard Error 0.28	-4.14 log10 copies/mL Standard Error 0.28	-5.03 log10 copies/mL Standard Error 0.27	-5.23 log10 copies/mL Standard Error 0.25	-5.14 log10 copies/mL Standard Error 0.18	—	—	—	—
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 Change at Day 22	-5.95 log10 copies/mL Standard Error 0.24	-5.85 log10 copies/mL Standard Error 0.17	-5.29 log10 copies/mL Standard Error 0.30	-5.74 log10 copies/mL Standard Error 0.24	-5.37 log10 copies/mL Standard Error 0.30	-5.75 log10 copies/mL Standard Error 0.29	-5.77 log10 copies/mL Standard Error 0.25	-5.75 log10 copies/mL Standard Error 0.19	—	—	—	—
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 Change at Day 29	-6.60 log10 copies/mL Standard Error 0.18	-6.54 log10 copies/mL Standard Error 0.13	-5.90 log10 copies/mL Standard Error 0.24	-6.46 log10 copies/mL Standard Error 0.18	-5.77 log10 copies/mL Standard Error 0.27	-6.34 log10 copies/mL Standard Error 0.26	-6.36 log10 copies/mL Standard Error 0.23	-6.35 log10 copies/mL Standard Error 0.17	—	—	—	—

SECONDARY outcome

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

Population: The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Number of Participants Analyzed" = participants with measurements at baseline. "Number Analyzed" = participants with measurements for both baseline and the specific study day. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=82 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=162 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=70 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=80 Participants 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).	Phase 2: Cohort 1A (Placebo) n=90 Participants Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) n=92 Participants 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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) n=106 Participants 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV n=198 Participants 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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 Percent change at Day 3	-88.15 Percent Change Interval -95.07 to -71.52	-87.94 Percent Change Interval -93.51 to -77.61	-92.04 Percent Change Interval -97.12 to -78.01	-87.52 Percent Change Interval -94.82 to -69.93	-85.92 Percent Change Interval -94.47 to -64.12	-90.65 Percent Change Interval -96.19 to -77.01	-96.15 Percent Change Interval -98.37 to -90.9	-94.15 Percent Change Interval -96.86 to -89.09	—	—	—	—
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 Percent change at Day 5	-98.76 Percent Change Interval -99.59 to -96.2	-99.23 Percent Change Interval -99.64 to -98.34	-98.92 Percent Change Interval -99.68 to -96.35	-99.48 Percent Change Interval -99.82 to -98.5	-97.18 Percent Change Interval -99.09 to -91.23	-99.38 Percent Change Interval -99.81 to -97.96	-99.42 Percent Change Interval -99.81 to -98.26	-99.39 Percent Change Interval -99.73 to -98.63	—	—	—	—
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 Percent change at Day 7	-99.94 Percent Change Interval -99.98 to -99.82	-99.92 Percent Change Interval -99.96 to -99.82	-98.92 Percent Change Interval -99.73 to -95.76	-99.88 Percent Change Interval -99.96 to -99.62	-99.49 Percent Change Interval -99.84 to -98.36	-99.91 Percent Change Interval -99.97 to -99.73	-99.97 Percent Change Interval -99.99 to -99.9	-99.95 Percent Change Interval -99.98 to -99.88	—	—	—	—
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 Percent change at Day 9	-99.99 Percent Change Interval -100.0 to -99.98	-99.99 Percent Change Interval -100.0 to -99.98	-99.72 Percent Change Interval -99.94 to -98.8	-99.99 Percent Change Interval -100.0 to -99.96	-99.87 Percent Change Interval -99.96 to -99.56	-99.98 Percent Change Interval -99.99 to -99.94	-99.99 Percent Change Interval -100.0 to -99.96	-99.98 Percent Change Interval -99.99 to -99.97	—	—	—	—
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 Percent change at Day 11	-100.00 Percent Change Interval -100.0 to -99.99	-100.00 Percent Change Interval -100.0 to -99.99	-99.94 Percent Change Interval -99.99 to -99.7	-99.99 Percent Change Interval -100.0 to -99.98	-99.99 Percent Change Interval -100.0 to -99.94	-100.00 Percent Change Interval -100.0 to -99.99	-100.00 Percent Change Interval -100.0 to -99.98	-100.00 Percent Change Interval -100.0 to -99.99	—	—	—	—
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 Percent change at Day 13	-100.00 Percent Change Interval -100.0 to -100.0	-100.00 Percent Change Interval -100.0 to -100.0	-99.98 Percent Change Interval -100.0 to -99.91	-100.00 Percent Change Interval -100.0 to -100.0	-99.99 Percent Change Interval -100.0 to -99.98	-100.00 Percent Change Interval -100.0 to -99.99	-100.00 Percent Change Interval -100.0 to -100.0	-100.00 Percent Change Interval -100.0 to -100.0	—	—	—	—
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 Percent change at Day 15	-100.00 Percent Change Interval -100.0 to -100.0	-100.00 Percent Change Interval -100.0 to -100.0	-100.00 Percent Change Interval -100.0 to -99.98	-100.00 Percent Change Interval -100.0 to -100.0	-99.99 Percent Change Interval -100.0 to -99.97	-100.00 Percent Change Interval -100.0 to -100.0	-100.00 Percent Change Interval -100.0 to -100.0	-100.00 Percent Change Interval -100.0 to -100.0	—	—	—	—
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 Percent change at Day 22	-100.00 Percent Change Interval -100.0 to -100.0	-100.00 Percent Change Interval -100.0 to -100.0	-100.00 Percent Change Interval -100.0 to -100.0	-100.00 Percent Change Interval -100.0 to -100.0	-100.00 Percent Change Interval -100.0 to -100.0	-100.00 Percent Change Interval -100.0 to -100.0	-100.00 Percent Change Interval -100.0 to -100.0	-100.00 Percent Change Interval -100.0 to -100.0	—	—	—	—
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 Percent change at Day 29	-100.00 Percent Change Interval -100.0 to -100.0	-100.00 Percent Change Interval -100.0 to -100.0	-100.00 Percent Change Interval -100.0 to -100.0	-100.00 Percent Change Interval -100.0 to -100.0	-100.00 Percent Change Interval -100.0 to -100.0	-100.00 Percent Change Interval -100.0 to -100.0	-100.00 Percent Change Interval -100.0 to -100.0	-100.00 Percent Change Interval -100.0 to -100.0	—	—	—	—

SECONDARY outcome

Timeframe: by Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\>) 10\^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=118 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=247 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=126 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=129 Participants 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).	Phase 2: Cohort 1A (Placebo) n=103 Participants Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) n=102 Participants 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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) n=118 Participants 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV n=220 Participants 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	16.9 Percentage of Participants Interval 10.7 to 25.0	12.6 Percentage of Participants Interval 8.7 to 17.3	17.5 Percentage of Participants Interval 11.3 to 25.2	8.5 Percentage of Participants Interval 4.3 to 14.7	3.9 Percentage of Participants Interval 1.1 to 9.6	2.9 Percentage of Participants Interval 0.6 to 8.4	0.0 Percentage of Participants Interval 0.0 to 0.0	1.4 Percentage of Participants Interval 0.3 to 3.9	—	—	—	—

SECONDARY outcome

Timeframe: Day 6 to Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\>) 10\^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=115 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=243 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=122 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=128 Participants 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).	Phase 2: Cohort 1A (Placebo) n=100 Participants Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) n=98 Participants 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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) n=113 Participants 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV n=211 Participants 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	15.7 Percentage of Participants Interval 9.5 to 23.6	12.8 Percentage of Participants Interval 8.8 to 17.6	18.0 Percentage of Participants Interval 11.7 to 26.0	10.2 Percentage of Participants Interval 5.5 to 16.7	7.0 Percentage of Participants Interval 2.9 to 13.9	3.1 Percentage of Participants Interval 0.6 to 8.7	4.4 Percentage of Participants Interval 1.5 to 10.0	3.8 Percentage of Participants Interval 1.7 to 7.3	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 to Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\>) 10\^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=118 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=247 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=126 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=129 Participants 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).	Phase 2: Cohort 1A (Placebo) n=103 Participants Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) n=102 Participants 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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) n=118 Participants 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV n=220 Participants 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	16.9 Percentage of Participants Interval 10.7 to 25.0	13.8 Percentage of Participants Interval 9.7 to 18.7	20.6 Percentage of Participants Interval 13.9 to 28.8	10.9 Percentage of Participants Interval 6.1 to 17.5	6.8 Percentage of Participants Interval 2.8 to 13.5	2.9 Percentage of Participants Interval 0.6 to 8.4	5.1 Percentage of Participants Interval 1.9 to 10.7	4.1 Percentage of Participants Interval 1.9 to 7.6	—	—	—	—

SECONDARY outcome

Timeframe: by Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\>) 10\^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=118 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=247 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=126 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=129 Participants 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).	Phase 2: Cohort 1A (Placebo) n=103 Participants Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) n=102 Participants 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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) n=118 Participants 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV n=220 Participants 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS	78.8 Percentage of Participants Interval 70.3 to 85.8	81.4 Percentage of Participants Interval 76.0 to 86.0	72.2 Percentage of Participants Interval 63.5 to 79.8	83.7 Percentage of Participants Interval 76.2 to 89.6	90.3 Percentage of Participants Interval 82.9 to 95.2	96.1 Percentage of Participants Interval 90.3 to 98.9	94.9 Percentage of Participants Interval 89.3 to 98.1	95.5 Percentage of Participants Interval 91.8 to 97.8	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\>) 10\^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=118 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=247 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=126 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=129 Participants 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).	Phase 2: Cohort 1A (Placebo) n=103 Participants Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) n=102 Participants 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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) n=118 Participants 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV n=220 Participants 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	22.9 Percentage of Participants Interval 15.7 to 31.5	20.6 Percentage of Participants Interval 15.8 to 26.2	24.6 Percentage of Participants Interval 17.4 to 33.1	18.6 Percentage of Participants Interval 12.3 to 26.4	16.5 Percentage of Participants Interval 9.9 to 25.1	10.8 Percentage of Participants Interval 5.5 to 18.5	11.9 Percentage of Participants Interval 6.6 to 19.1	11.4 Percentage of Participants Interval 7.5 to 16.3	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\>) 10\^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=90 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=200 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=96 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=110 Participants 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).	Phase 2: Cohort 1A (Placebo) n=85 Participants Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) n=91 Participants 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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) n=100 Participants 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV n=191 Participants 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death Over Time Based on High Viral Load mFAS	17.9 Cumulative Incidence Percentage Interval 11.9 to 26.3	14.3 Cumulative Incidence Percentage Interval 10.5 to 19.5	21.1 Cumulative Incidence Percentage Interval 14.9 to 29.4	11.2 Cumulative Incidence Percentage Interval 6.8 to 18.2	7.2 Cumulative Incidence Percentage Interval 3.5 to 14.4	3.1 Cumulative Incidence Percentage Interval 1.0 to 9.4	5.3 Cumulative Incidence Percentage Interval 2.4 to 11.5	4.3 Cumulative Incidence Percentage Interval 2.3 to 8.2	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\>) 10\^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=83 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=187 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=87 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=104 Participants 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).	Phase 2: Cohort 1A (Placebo) n=83 Participants Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) n=90 Participants 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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) n=100 Participants 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV n=190 Participants 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation Over Time Based on High Viral Load mFAS	18.0 Cumulative Incidence Percentage Interval 12.0 to 26.5	13.1 Cumulative Incidence Percentage Interval 9.4 to 18.1	18.1 Cumulative Incidence Percentage Interval 12.3 to 26.2	8.8 Cumulative Incidence Percentage Interval 5.0 to 15.3	4.0 Cumulative Incidence Percentage Interval 1.5 to 10.4	3.1 Cumulative Incidence Percentage Interval 1.0 to 9.2	0.0 Cumulative Incidence Percentage Interval 0.0 to 0.0	1.5 Cumulative Incidence Percentage Interval 0.5 to 4.5	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\>) 10\^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=83 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=187 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=87 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=104 Participants 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).	Phase 2: Cohort 1A (Placebo) n=83 Participants Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) n=90 Participants 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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) n=100 Participants 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV n=190 Participants 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation Over Time Based on High Viral Load mFAS	24.4 Cumulative Incidence Percentage Interval 17.6 to 33.4	19.5 Cumulative Incidence Percentage Interval 15.0 to 25.1	27.2 Cumulative Incidence Percentage Interval 20.2 to 35.9	15.0 Cumulative Incidence Percentage Interval 9.8 to 22.5	9.1 Cumulative Incidence Percentage Interval 4.9 to 16.8	4.1 Cumulative Incidence Percentage Interval 1.6 to 10.5	5.3 Cumulative Incidence Percentage Interval 2.4 to 11.5	4.8 Cumulative Incidence Percentage Interval 2.6 to 8.7	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 56

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\>) 10\^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 \[Cohort 1\] and Phase 2 \[Cohort 1A\].

Time to Discharge in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=118 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=247 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=126 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=129 Participants 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).	Phase 2: Cohort 1A (Placebo) n=103 Participants Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) n=102 Participants 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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) n=118 Participants 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV n=220 Participants 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge Based on High Viral Load mFAS	7.0 days Interval 5.0 to 8.0	7.0 days Interval 6.0 to 8.0	7.0 days Interval 5.0 to 10.0	7.0 days Interval 5.0 to 8.0	4.0 days Interval 3.0 to 4.0	3.0 days Interval 2.0 to 4.0	3.0 days Interval 2.0 to 3.0	3.0 days Interval 3.0 to 3.0	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 29

Population: Seronegative modified full analysis set (mFAS) = all participants in mFAS with documented seroneg status at baseline. "Number of Participants Analyzed" = participants with measurements at baseline. "Number Analyzed" = participants with measurements at both baseline and specific study day. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected/reported for Phase 1 \[Cohort 1\] and Phase 2 \[Cohort 1\].

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=70 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=149 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=68 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=79 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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 Time-weighted average change from baseline from Day 1 to Day 29	-2.95 log10 copies/milliliter (mL) Standard Error 0.24	-2.97 log10 copies/milliliter (mL) Standard Error 0.17	-2.35 log10 copies/milliliter (mL) Standard Error 0.24	-2.98 log10 copies/milliliter (mL) Standard Error 0.23	—	—	—	—	—	—	—	—
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 Time-weighted average change from baseline from Day 1 to Day 3	-0.60 log10 copies/milliliter (mL) Standard Error 0.12	-0.50 log10 copies/milliliter (mL) Standard Error 0.08	-0.33 log10 copies/milliliter (mL) Standard Error 0.11	-0.40 log10 copies/milliliter (mL) Standard Error 0.11	—	—	—	—	—	—	—	—
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 Time-weighted average change from baseline from Day 1 to Day 5	-0.92 log10 copies/milliliter (mL) Standard Error 0.14	-0.89 log10 copies/milliliter (mL) Standard Error 0.10	-0.55 log10 copies/milliliter (mL) Standard Error 0.14	-0.86 log10 copies/milliliter (mL) Standard Error 0.14	—	—	—	—	—	—	—	—
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 Time-weighted average change from baseline from Day 1 to Day 7	-1.23 log10 copies/milliliter (mL) Standard Error 0.14	-1.23 log10 copies/milliliter (mL) Standard Error 0.10	-0.70 log10 copies/milliliter (mL) Standard Error 0.14	-1.23 log10 copies/milliliter (mL) Standard Error 0.14	—	—	—	—	—	—	—	—
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 Time-weighted average change from baseline from Day 1 to Day 9	-1.58 log10 copies/milliliter (mL) Standard Error 0.16	-1.52 log10 copies/milliliter (mL) Standard Error 0.11	-0.93 log10 copies/milliliter (mL) Standard Error 0.16	-1.47 log10 copies/milliliter (mL) Standard Error 0.15	—	—	—	—	—	—	—	—
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 Time-weighted average change from baseline from Day 1 to Day 11	-1.78 log10 copies/milliliter (mL) Standard Error 0.17	-1.75 log10 copies/milliliter (mL) Standard Error 0.12	-1.12 log10 copies/milliliter (mL) Standard Error 0.16	-1.72 log10 copies/milliliter (mL) Standard Error 0.16	—	—	—	—	—	—	—	—
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 Time-weighted average change from baseline from Day 1 to Day 13	-1.95 log10 copies/milliliter (mL) Standard Error 0.18	-1.96 log10 copies/milliliter (mL) Standard Error 0.12	-1.33 log10 copies/milliliter (mL) Standard Error 0.18	-1.96 log10 copies/milliliter (mL) Standard Error 0.17	—	—	—	—	—	—	—	—
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 Time-weighted average change from baseline from Day 1 to Day 15	-2.16 log10 copies/milliliter (mL) Standard Error 0.19	-2.18 log10 copies/milliliter (mL) Standard Error 0.13	-1.50 log10 copies/milliliter (mL) Standard Error 0.19	-2.19 log10 copies/milliliter (mL) Standard Error 0.18	—	—	—	—	—	—	—	—
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 Time-weighted average change from baseline from Day 1 to Day 22	-2.64 log10 copies/milliliter (mL) Standard Error 0.22	-2.63 log10 copies/milliliter (mL) Standard Error 0.15	-1.89 log10 copies/milliliter (mL) Standard Error 0.22	-2.62 log10 copies/milliliter (mL) Standard Error 0.21	—	—	—	—	—	—	—	—

SECONDARY outcome

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

Population: Seronegative modified full analysis set (mFAS) = all participants in mFAS with documented seroneg status at baseline. "Number of Participants Analyzed" = participants with measurements at baseline. "Number Analyzed" = participants with measurements at both baseline and specific study day. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected/reported for Phase 1 \[Cohort 1\] and Phase 2 \[Cohort 1\].

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.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=70 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=149 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=68 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=79 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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 Time-weighted average change from baseline from Day 1 to Day 3	-1.08 log10 copies/milliliter (mL) Standard Error 0.23	-0.94 log10 copies/milliliter (mL) Standard Error 0.16	-0.66 log10 copies/milliliter (mL) Standard Error 0.22	-0.81 log10 copies/milliliter (mL) Standard Error 0.21	—	—	—	—	—	—	—	—
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 Time-weighted average change from baseline from Day 1 to Day 5	-2.28 log10 copies/milliliter (mL) Standard Error 0.27	-2.18 log10 copies/milliliter (mL) Standard Error 0.19	-1.18 log10 copies/milliliter (mL) Standard Error 0.26	-2.08 log10 copies/milliliter (mL) Standard Error 0.26	—	—	—	—	—	—	—	—
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 Time-weighted average change from baseline from Day 1 to Day 7	-2.56 log10 copies/milliliter (mL) Standard Error 0.29	-2.67 log10 copies/milliliter (mL) Standard Error 0.20	-1.62 log10 copies/milliliter (mL) Standard Error 0.30	-2.76 log10 copies/milliliter (mL) Standard Error 0.27	—	—	—	—	—	—	—	—
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 Time-weighted average change from baseline from Day 1 to Day 9	-3.16 log10 copies/milliliter (mL) Standard Error 0.32	-3.20 log10 copies/milliliter (mL) Standard Error 0.22	-2.68 log10 copies/milliliter (mL) Standard Error 0.34	-3.24 log10 copies/milliliter (mL) Standard Error 0.31	—	—	—	—	—	—	—	—
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 Time-weighted average change from baseline from Day 1 to Day 11	-3.94 log10 copies/milliliter (mL) Standard Error 0.37	-3.87 log10 copies/milliliter (mL) Standard Error 0.26	-3.55 log10 copies/milliliter (mL) Standard Error 0.39	-3.74 log10 copies/milliliter (mL) Standard Error 0.38	—	—	—	—	—	—	—	—
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 Time-weighted average change from baseline from Day 1 to Day 13	-4.25 log10 copies/milliliter (mL) Standard Error 0.39	-4.68 log10 copies/milliliter (mL) Standard Error 0.26	-3.04 log10 copies/milliliter (mL) Standard Error 0.38	-5.01 log10 copies/milliliter (mL) Standard Error 0.35	—	—	—	—	—	—	—	—
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 Time-weighted average change from baseline from Day 1 to Day 15	-5.01 log10 copies/milliliter (mL) Standard Error 0.36	-4.84 log10 copies/milliliter (mL) Standard Error 0.25	-4.60 log10 copies/milliliter (mL) Standard Error 0.39	-4.67 log10 copies/milliliter (mL) Standard Error 0.35	—	—	—	—	—	—	—	—
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 Time-weighted average change from baseline from Day 1 to Day 22	-5.25 log10 copies/milliliter (mL) Standard Error 0.32	-5.23 log10 copies/milliliter (mL) Standard Error 0.22	-5.89 log10 copies/milliliter (mL) Standard Error 0.37	-5.21 log10 copies/milliliter (mL) Standard Error 0.31	—	—	—	—	—	—	—	—
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 Time-weighted average change from baseline from Day 1 to Day 29	-6.16 log10 copies/milliliter (mL) Standard Error 0.28	-6.10 log10 copies/milliliter (mL) Standard Error 0.20	-6.01 log10 copies/milliliter (mL) Standard Error 0.32	-6.04 log10 copies/milliliter (mL) Standard Error 0.27	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through Day 29

Population: Seronegative modified full analysis set (mFAS) was defined as all participants in mFAS with documented seronegative status at the baseline. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 1 \[Cohort 1\] and Phase 2 \[Cohort 1\].

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=59 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=121 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=52 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=62 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	22.0 Percentage of Participants Interval 15.1 to 28.9	19.8 Percentage of Participants Interval 15.2 to 24.5	26.9 Percentage of Participants Interval 19.0 to 34.8	17.7 Percentage of Participants Interval 11.5 to 24.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through Day 29

Population: The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (\>) 10\^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 1 \[Cohort 1\] and Phase 2 \[Cohort 1\].

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=80 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=157 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=78 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=77 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
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	13.8 Percentage of Participants Interval 8.8 to 18.7	18.5 Percentage of Participants Interval 14.5 to 22.4	23.1 Percentage of Participants Interval 17.0 to 29.2	23.4 Percentage of Participants Interval 17.2 to 29.6	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 28

Population: Participants in Phase 1 (Cohort 1) who received any study drug of casirivimab and imdevimab and who had at least 1 non-missing drug concentration measurement following the first dose of study drug

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=16 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=20 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Phase 1 [Cohort 1]: Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28) AUC0-28 of Casirivimab	—	—	3026 day*mg/L Standard Deviation 719	9678 day*mg/L Standard Deviation 3362	—	—	—	—	—	—	—	—
Phase 1 [Cohort 1]: Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28) AUC0-28 of Imdevimab	—	—	2582 day*mg/L Standard Deviation 581	8680 day*mg/L Standard Deviation 2930	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1

Population: Participants who received any study drug of casirivimab and imdevimab

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=167 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=155 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=16 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=20 Participants 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).	Phase 2: Cohort 1A (Placebo) n=181 Participants Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) n=178 Participants 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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) n=55 Participants 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV n=50 Participants 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV n=10 Participants Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV n=11 Participants Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV n=214 Participants 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV n=207 Participants 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).
Concentration at the End of Infusion (Ceoi) Ceoi of Casirivimab	272 milligrams per liter (mg/L) Standard Deviation 124	847 milligrams per liter (mg/L) Standard Deviation 300	231 milligrams per liter (mg/L) Standard Deviation 110	776 milligrams per liter (mg/L) Standard Deviation 372	288 milligrams per liter (mg/L) Standard Deviation 86.8	848 milligrams per liter (mg/L) Standard Deviation 261	286 milligrams per liter (mg/L) Standard Deviation 93.5	921 milligrams per liter (mg/L) Standard Deviation 262	284 milligrams per liter (mg/L) Standard Deviation 69.3	708 milligrams per liter (mg/L) Standard Deviation 128	307 milligrams per liter (mg/L) Standard Deviation 153	908 milligrams per liter (mg/L) Standard Deviation 338
Concentration at the End of Infusion (Ceoi) Ceoi of Imdevimab	283 milligrams per liter (mg/L) Standard Deviation 127	868 milligrams per liter (mg/L) Standard Deviation 298	243 milligrams per liter (mg/L) Standard Deviation 117	795 milligrams per liter (mg/L) Standard Deviation 371	300 milligrams per liter (mg/L) Standard Deviation 87.3	880 milligrams per liter (mg/L) Standard Deviation 268	302 milligrams per liter (mg/L) Standard Deviation 94.0	946 milligrams per liter (mg/L) Standard Deviation 244	290 milligrams per liter (mg/L) Standard Deviation 81.7	738 milligrams per liter (mg/L) Standard Deviation 124	312 milligrams per liter (mg/L) Standard Deviation 157	945 milligrams per liter (mg/L) Standard Deviation 351

SECONDARY outcome

Timeframe: Day 28

Population: Participants who received any study drug of casirivimab and imdevimab and who had at least 1 non-missing drug concentration measurement following the first dose of study drug

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=91 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV n=96 Participants 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=9 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=9 Participants 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).	Phase 2: Cohort 1A (Placebo) n=91 Participants Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) n=93 Participants 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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) n=25 Participants 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV n=26 Participants 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV n=3 Participants Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV n=5 Participants Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV n=149 Participants 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV n=146 Participants 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).
Concentration at Day 28 (C28) C28 of Casirivimab	64.8 mg/L Standard Deviation 35.9	174 mg/L Standard Deviation 65.1	50.7 mg/L Standard Deviation 19.5	166 mg/L Standard Deviation 108	50.0 mg/L Standard Deviation 20.4	144 mg/L Standard Deviation 89.8	26.4 mg/L Standard Deviation 18.5	79.4 mg/L Standard Deviation 61.4	9.06 mg/L Standard Deviation 2.64	67.8 mg/L Standard Deviation 31.1	49.1 mg/L Standard Deviation 40.4	140 mg/L Standard Deviation 66.1
Concentration at Day 28 (C28) C28 of Imdevimab	54.7 mg/L Standard Deviation 37.6	150 mg/L Standard Deviation 62.9	36.1 mg/L Standard Deviation 16.1	131 mg/L Standard Deviation 84.1	39.8 mg/L Standard Deviation 18.9	113 mg/L Standard Deviation 68.8	18.7 mg/L Standard Deviation 14.7	60.0 mg/L Standard Deviation 53.9	5.25 mg/L Standard Deviation 4.12	52.4 mg/L Standard Deviation 24.7	40.8 mg/L Standard Deviation 48.3	114 mg/L Standard Deviation 62.6

SECONDARY outcome

Timeframe: Through Day 169

Population: ADA analysis set includes all treated participants from all phases/cohorts who received any amount of study drug and had at least one non-missing antibody variables result following the first dose of study drug or placebo.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=497 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=503 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=504 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933	484 Participants	—	489 Participants	471 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through Day 169

Population: ADA analysis set includes all treated participants from all phases/cohorts who received any amount of study drug and had at least one non-missing antibody variables result following the first dose of study drug or placebo.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=497 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=503 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=504 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987	463 Participants	—	467 Participants	444 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through Day 57

Population: NAb analysis set includes all Phase 2/3 treated participants who received any study drug, had at least one non-missing antibody result following the first dose of study drug, and either tested negative at all ADA sampling times or tested positive for ADA with at least one non-missing NAb result after first dose of the study drug.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=497 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=503 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=504 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10933 Anti-drug Antibody (ADA) Negative	484 Participants	—	489 Participants	471 Participants	—	—	—	—	—	—	—	—
Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10933 Neutralizing antibody (NAb) Positive	1 Participants	—	1 Participants	1 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through Day 57

Population: NAb analysis set includes all Phase 2/3 treated participants who received any study drug, had at least one non-missing antibody result following the first dose of study drug, and either tested negative at all ADA sampling times or tested positive for ADA with at least one non-missing NAb result after first dose of the study drug.

Outcome measures

Measure	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV) n=497 Participants 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	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV 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	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo n=503 Participants 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).	Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV) n=504 Participants 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).	Phase 2: Cohort 1A (Placebo) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.	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.	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV) 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	Phase 2 (Cohort 1A): Combined R10933+R10987 IV 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.	Phase 2 (Cohort 3): R10933+R10987 2400mg IV Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 (Cohort 3): R10933+R10987 8000mg IV Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 (Cohort 1): R10933+R10987 2400mg IV 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).	Phase 3 (Cohort 1): R10933+R10987 8000mg IV 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).
Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10987 Anti-drug Antibody (ADA) Negative	463 Participants	—	467 Participants	444 Participants	—	—	—	—	—	—	—	—
Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10987 Neutralizing antibody (NAb) Positive	4 Participants	—	9 Participants	10 Participants	—	—	—	—	—	—	—	—

Adverse Events

Phase 1 Cohort 1: Placebo IV

Serious events: 3 serious events

Other events: 0 other events

Deaths: 2 deaths

Phase 1 Cohort 1: R10933+R10987 2400mg IV

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Phase 1 Cohort 1: R10933+R10987 8000mg IV

Serious events: 2 serious events

Other events: 1 other events

Deaths: 1 deaths

Phase 2 Cohort 1A: Placebo IV

Serious events: 43 serious events

Other events: 0 other events

Deaths: 15 deaths

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

Serious events: 29 serious events

Other events: 0 other events

Deaths: 8 deaths

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

Serious events: 32 serious events

Other events: 0 other events

Deaths: 7 deaths

Phase 2 Cohort 1: Placebo IV

Serious events: 63 serious events

Other events: 0 other events

Deaths: 28 deaths

Phase 2 Cohort 1: R10933+R10987 2400mg IV

Serious events: 47 serious events

Other events: 0 other events

Deaths: 25 deaths

Phase 2 Cohort 1: R10933+R10987 8000mg IV

Serious events: 47 serious events

Other events: 0 other events

Deaths: 21 deaths

Phase 2 Cohort 2: Placebo IV

Serious events: 20 serious events

Other events: 0 other events

Deaths: 13 deaths

Phase 2 Cohort 2: R10933+R10987 2400mg IV

Serious events: 31 serious events

Other events: 0 other events

Deaths: 25 deaths

Phase 2 Cohort 2: R10933+R10987 8000mg IV

Serious events: 26 serious events

Other events: 0 other events

Deaths: 19 deaths

Phase 2 Cohort 3: Placebo IV

Serious events: 9 serious events

Other events: 0 other events

Deaths: 7 deaths

Phase 2 Cohort 3: R10933+R10987 2400mg IV

Serious events: 11 serious events

Other events: 1 other events

Deaths: 8 deaths

Phase 2 Cohort 3: R10933+R10987 8000mg IV

Serious events: 5 serious events

Other events: 1 other events

Deaths: 4 deaths

Phase 3 Cohort 1: Placebo IV

Serious events: 65 serious events

Other events: 0 other events

Deaths: 42 deaths

Phase 3 Cohort 1: R10933+R10987 2400mg IV

Serious events: 56 serious events

Other events: 1 other events

Deaths: 24 deaths

Phase 3 Cohort 1: R10933+R10987 8000mg IV

Serious events: 69 serious events

Other events: 2 other events

Deaths: 37 deaths

Serious adverse events

Measure	Phase 1 Cohort 1: Placebo IV n=18 participants at risk 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 1 (Cohort 1).	Phase 1 Cohort 1: R10933+R10987 2400mg IV n=18 participants at risk 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).	Phase 1 Cohort 1: R10933+R10987 8000mg IV n=20 participants at risk 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).	Phase 2 Cohort 1A: Placebo IV n=198 participants at risk 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).	Phase 2 Cohort 1A: R10933+R10987 2400mg IV n=202 participants at risk 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).	Phase 2 Cohort 1A: R10933+R10987 8000mg IV n=197 participants at risk 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).	Phase 2 Cohort 1: Placebo IV n=204 participants at risk 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 2 (Cohort 1).	Phase 2 Cohort 1: R10933+R10987 2400mg IV n=206 participants at risk 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).	Phase 2 Cohort 1: R10933+R10987 8000mg IV n=205 participants at risk 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 2 (Cohort 1).	Phase 2 Cohort 2: Placebo IV n=51 participants at risk 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).	Phase 2 Cohort 2: R10933+R10987 2400mg IV n=56 participants at risk 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).	Phase 2 Cohort 2: R10933+R10987 8000mg IV n=54 participants at risk 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).	Phase 2 Cohort 3: Placebo IV n=12 participants at risk Participants on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 Cohort 3: R10933+R10987 2400mg IV n=12 participants at risk Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 Cohort 3: R10933+R10987 8000mg IV n=11 participants at risk Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 Cohort 1: Placebo IV n=247 participants at risk 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).	Phase 3 Cohort 1: R10933+R10987 2400mg IV n=246 participants at risk 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).	Phase 3 Cohort 1: R10933+R10987 8000mg IV n=246 participants at risk 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).
Investigations Mean arterial pressure increased	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Investigations Oxygen saturation decreased	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.6% 1/18 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	1.0% 2/198 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	1.5% 3/197 • Number of events 3 • From first dose of study drug to Day 169	0.98% 2/204 • Number of events 2 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.81% 2/247 • Number of events 2 • From first dose of study drug to Day 169	1.2% 3/246 • Number of events 3 • From first dose of study drug to Day 169	1.2% 3/246 • Number of events 4 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Hypoxia	5.6% 1/18 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	1.5% 3/198 • Number of events 3 • From first dose of study drug to Day 169	0.50% 1/202 • Number of events 1 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	3.4% 7/204 • Number of events 9 • From first dose of study drug to Day 169	1.5% 3/206 • Number of events 3 • From first dose of study drug to Day 169	3.4% 7/205 • Number of events 7 • From first dose of study drug to Day 169	2.0% 1/51 • Number of events 1 • From first dose of study drug to Day 169	1.8% 1/56 • Number of events 1 • From first dose of study drug to Day 169	3.7% 2/54 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	3.2% 8/247 • Number of events 9 • From first dose of study drug to Day 169	3.3% 8/246 • Number of events 8 • From first dose of study drug to Day 169	2.0% 5/246 • Number of events 6 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.6% 1/18 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.98% 2/204 • Number of events 2 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	7.1% 4/56 • Number of events 4 • From first dose of study drug to Day 169	3.7% 2/54 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.81% 2/247 • Number of events 2 • From first dose of study drug to Day 169	1.2% 3/246 • Number of events 3 • From first dose of study drug to Day 169	0.81% 2/246 • Number of events 2 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	5.0% 1/20 • Number of events 1 • From first dose of study drug to Day 169	2.5% 5/198 • Number of events 5 • From first dose of study drug to Day 169	0.99% 2/202 • Number of events 2 • From first dose of study drug to Day 169	1.0% 2/197 • Number of events 2 • From first dose of study drug to Day 169	2.9% 6/204 • Number of events 6 • From first dose of study drug to Day 169	4.9% 10/206 • Number of events 10 • From first dose of study drug to Day 169	2.4% 5/205 • Number of events 5 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	12.5% 7/56 • Number of events 7 • From first dose of study drug to Day 169	5.6% 3/54 • Number of events 3 • From first dose of study drug to Day 169	16.7% 2/12 • Number of events 2 • From first dose of study drug to Day 169	8.3% 1/12 • Number of events 1 • From first dose of study drug to Day 169	9.1% 1/11 • Number of events 1 • From first dose of study drug to Day 169	4.5% 11/247 • Number of events 12 • From first dose of study drug to Day 169	2.4% 6/246 • Number of events 6 • From first dose of study drug to Day 169	2.0% 5/246 • Number of events 6 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Alveolar lung disease	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	9.1% 1/11 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.50% 1/202 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.81% 2/246 • Number of events 3 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Laryngeal stenosis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	8.3% 1/12 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	2.0% 1/51 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	2.0% 1/51 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.50% 1/202 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	3.6% 2/56 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	8.3% 1/12 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Pulmonary artery thrombosis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.99% 2/202 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.98% 2/204 • Number of events 2 • From first dose of study drug to Day 169	2.4% 5/206 • Number of events 5 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	1.9% 1/54 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.81% 2/247 • Number of events 2 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	8.3% 1/12 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	1.8% 1/56 • Number of events 1 • From first dose of study drug to Day 169	1.9% 1/54 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.99% 2/202 • Number of events 3 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	4.4% 9/204 • Number of events 10 • From first dose of study drug to Day 169	1.9% 4/206 • Number of events 4 • From first dose of study drug to Day 169	2.9% 6/205 • Number of events 8 • From first dose of study drug to Day 169	9.8% 5/51 • Number of events 6 • From first dose of study drug to Day 169	7.1% 4/56 • Number of events 4 • From first dose of study drug to Day 169	9.3% 5/54 • Number of events 6 • From first dose of study drug to Day 169	8.3% 1/12 • Number of events 1 • From first dose of study drug to Day 169	25.0% 3/12 • Number of events 3 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	2.8% 7/247 • Number of events 8 • From first dose of study drug to Day 169	2.8% 7/246 • Number of events 7 • From first dose of study drug to Day 169	2.0% 5/246 • Number of events 5 • From first dose of study drug to Day 169
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations COVID-19	5.6% 1/18 • Number of events 1 • From first dose of study drug to Day 169	5.6% 1/18 • Number of events 1 • From first dose of study drug to Day 169	5.0% 1/20 • Number of events 1 • From first dose of study drug to Day 169	3.5% 7/198 • Number of events 7 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	3.0% 6/197 • Number of events 6 • From first dose of study drug to Day 169	2.9% 6/204 • Number of events 6 • From first dose of study drug to Day 169	1.9% 4/206 • Number of events 4 • From first dose of study drug to Day 169	3.4% 7/205 • Number of events 7 • From first dose of study drug to Day 169	7.8% 4/51 • Number of events 4 • From first dose of study drug to Day 169	12.5% 7/56 • Number of events 7 • From first dose of study drug to Day 169	14.8% 8/54 • Number of events 10 • From first dose of study drug to Day 169	16.7% 2/12 • Number of events 2 • From first dose of study drug to Day 169	8.3% 1/12 • Number of events 1 • From first dose of study drug to Day 169	18.2% 2/11 • Number of events 2 • From first dose of study drug to Day 169	4.0% 10/247 • Number of events 10 • From first dose of study drug to Day 169	2.0% 5/246 • Number of events 5 • From first dose of study drug to Day 169	3.3% 8/246 • Number of events 9 • From first dose of study drug to Day 169
Infections and infestations Appendicitis perforated	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Arthritis bacterial	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Aspergillus infection	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	1.9% 1/54 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Burkholderia cepacia complex infection	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	1.9% 1/54 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations COVID-19 pneumonia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	2.0% 4/198 • Number of events 4 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.98% 2/204 • Number of events 2 • From first dose of study drug to Day 169	0.97% 2/206 • Number of events 2 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	5.9% 3/51 • Number of events 3 • From first dose of study drug to Day 169	3.6% 2/56 • Number of events 2 • From first dose of study drug to Day 169	5.6% 3/54 • Number of events 3 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	2.0% 5/247 • Number of events 5 • From first dose of study drug to Day 169	1.2% 3/246 • Number of events 3 • From first dose of study drug to Day 169	2.8% 7/246 • Number of events 7 • From first dose of study drug to Day 169
Infections and infestations Candida infection	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	2.0% 1/51 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Metabolism and nutrition disorders Acidosis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	5.0% 1/20 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Candida sepsis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	8.3% 1/12 • Number of events 1 • From first dose of study drug to Day 169	9.1% 1/11 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Cellulitis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.50% 1/202 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Cytomegalovirus infection	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	1.9% 1/54 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Device related bacteraemia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 2 • From first dose of study drug to Day 169
Infections and infestations Emphysematous cholecystitis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Infections and infestations Encephalitis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Enterococcal infection	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Escherichia urinary tract infection	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	1.9% 1/54 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Fungaemia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Infections and infestations Herpes simplex	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	2.0% 1/51 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Herpes zoster	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Ophthalmic herpes zoster	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	1.9% 1/54 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Osteomyelitis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Osteomyelitis fungal	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Perirectal abscess	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Pneumococcal infection	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Pneumonia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	2.5% 5/204 • Number of events 5 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	1.5% 3/205 • Number of events 3 • From first dose of study drug to Day 169	2.0% 1/51 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	1.9% 1/54 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.81% 2/247 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	1.2% 3/246 • Number of events 4 • From first dose of study drug to Day 169
Infections and infestations Pneumonia bacterial	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.50% 1/202 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	1.5% 3/204 • Number of events 3 • From first dose of study drug to Day 169	1.9% 4/206 • Number of events 4 • From first dose of study drug to Day 169	0.98% 2/205 • Number of events 2 • From first dose of study drug to Day 169	2.0% 1/51 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Pneumonia klebsiella	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	1.9% 1/54 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Pneumonia serratia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Pneumonia staphylococcal	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	1.8% 1/56 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Post procedural infection	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	2.0% 1/51 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Pseudomonal sepsis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.50% 1/202 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Pulmonary sepsis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	1.2% 3/247 • Number of events 3 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Pyelonephritis acute	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Scrotal abscess	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.50% 1/202 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Sepsis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	1.0% 2/198 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	2.0% 4/204 • Number of events 4 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	1.5% 3/205 • Number of events 3 • From first dose of study drug to Day 169	2.0% 1/51 • Number of events 1 • From first dose of study drug to Day 169	1.8% 1/56 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Septic shock	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	5.0% 1/20 • Number of events 1 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	1.5% 3/204 • Number of events 3 • From first dose of study drug to Day 169	0.97% 2/206 • Number of events 2 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	3.9% 2/51 • Number of events 2 • From first dose of study drug to Day 169	3.6% 2/56 • Number of events 2 • From first dose of study drug to Day 169	1.9% 1/54 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	2.4% 6/247 • Number of events 7 • From first dose of study drug to Day 169	0.81% 2/246 • Number of events 2 • From first dose of study drug to Day 169	2.0% 5/246 • Number of events 6 • From first dose of study drug to Day 169
Infections and infestations Serratia infection	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Infections and infestations Staphylococcal bacteraemia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	1.8% 1/56 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Staphylococcal infection	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	3.9% 2/51 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	8.3% 1/12 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Staphylococcal sepsis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	9.1% 1/11 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Superinfection bacterial	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	1.8% 1/56 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.81% 2/247 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Urinary tract candidiasis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Urinary tract infection	0.00% 0/18 • From first dose of study drug to Day 169	5.6% 1/18 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.50% 1/202 • Number of events 1 • From first dose of study drug to Day 169	1.0% 2/197 • Number of events 2 • From first dose of study drug to Day 169	0.98% 2/204 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Urinary tract infection enterococcal	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Urosepsis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.50% 1/202 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Viral cardiomyopathy	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	8.3% 1/12 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Viral myocarditis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Renal and urinary disorders Acute kidney injury	5.6% 1/18 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	5.0% 1/20 • Number of events 2 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.50% 1/202 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.98% 2/204 • Number of events 2 • From first dose of study drug to Day 169	0.97% 2/206 • Number of events 2 • From first dose of study drug to Day 169	1.5% 3/205 • Number of events 3 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	1.8% 1/56 • Number of events 1 • From first dose of study drug to Day 169	7.4% 4/54 • Number of events 4 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	8.3% 1/12 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	1.6% 4/247 • Number of events 4 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Renal and urinary disorders End stage renal disease	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Renal and urinary disorders Haematuria	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Renal and urinary disorders Renal failure	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.98% 2/204 • Number of events 2 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	2.0% 1/51 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Renal and urinary disorders Renal impairment	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	9.1% 1/11 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Renal and urinary disorders Renal tubular injury	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Renal and urinary disorders Ureterolithiasis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	1.8% 1/56 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Blood and lymphatic system disorders Anaemia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	5.0% 1/20 • Number of events 1 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	8.3% 1/12 • Number of events 1 • From first dose of study drug to Day 169	8.3% 1/12 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.81% 2/247 • Number of events 4 • From first dose of study drug to Day 169	0.81% 2/246 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.50% 1/202 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Blood and lymphatic system disorders Hypercoagulation	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Blood and lymphatic system disorders Sickle cell anaemia with crisis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	5.0% 1/20 • Number of events 1 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	2.0% 1/51 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Cardiac disorders Acute coronary syndrome	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Cardiac disorders Acute left ventricular failure	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Cardiac disorders Acute myocardial infarction	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	2.0% 1/51 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.81% 2/246 • Number of events 2 • From first dose of study drug to Day 169
Cardiac disorders Angina pectoris	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Cardiac disorders Atrial fibrillation	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	5.0% 1/20 • Number of events 1 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 2 • From first dose of study drug to Day 169	0.50% 1/202 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	1.5% 3/204 • Number of events 3 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Cardiac disorders Atrial flutter	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Cardiac disorders Atrial tachycardia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	1.8% 1/56 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Cardiac disorders Bradycardia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	1.8% 1/56 • Number of events 1 • From first dose of study drug to Day 169	1.9% 1/54 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Cardiac disorders Cardiac arrest	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	1.0% 2/198 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	1.5% 3/206 • Number of events 3 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	3.9% 2/51 • Number of events 3 • From first dose of study drug to Day 169	3.6% 2/56 • Number of events 5 • From first dose of study drug to Day 169	5.6% 3/54 • Number of events 4 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	8.3% 1/12 • Number of events 2 • From first dose of study drug to Day 169	9.1% 1/11 • Number of events 1 • From first dose of study drug to Day 169	0.81% 2/247 • Number of events 2 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Cardiac disorders Cardiac failure	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.50% 1/202 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.81% 2/247 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.81% 2/246 • Number of events 2 • From first dose of study drug to Day 169
Cardiac disorders Cardiac failure acute	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Cardiac disorders Cardiac failure chronic	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Cardiac disorders Cardiac failure congestive	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.81% 2/246 • Number of events 2 • From first dose of study drug to Day 169
Cardiac disorders Cardio-respiratory arrest	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	1.2% 3/247 • Number of events 4 • From first dose of study drug to Day 169	1.2% 3/246 • Number of events 3 • From first dose of study drug to Day 169	0.81% 2/246 • Number of events 2 • From first dose of study drug to Day 169
Cardiac disorders Cardiogenic shock	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.81% 2/247 • Number of events 2 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Cardiac disorders Chronic left ventricular failure	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Cardiac disorders Myocardial infarction	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	8.3% 1/12 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Cardiac disorders Myocarditis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Cardiac disorders Pulseless electrical activity	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Cardiac disorders Tachycardia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.97% 2/206 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Cardiac disorders Ventricular tachycardia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Ear and labyrinth disorders Vertigo positional	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Eye disorders Blindness unilateral	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Gastrointestinal disorders Abdominal distension	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Gastrointestinal disorders Abdominal pain	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Gastrointestinal disorders Abdominal pain upper	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Gastrointestinal disorders Dysphagia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	8.3% 1/12 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Gastrointestinal disorders Haematemesis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Gastrointestinal disorders Haematochezia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Gastrointestinal disorders Ileus	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	1.9% 1/54 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	2.0% 1/51 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Gastrointestinal disorders Intestinal obstruction	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Gastrointestinal disorders Mallory-Weiss syndrome	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Gastrointestinal disorders Pancreatitis acute	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	5.0% 1/20 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Gastrointestinal disorders Retroperitoneal haematoma	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Gastrointestinal disorders Retroperitoneal haemorrhage	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	1.9% 1/54 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
General disorders Asthenia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.99% 2/202 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.81% 2/246 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
General disorders Chest pain	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.50% 1/202 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.81% 2/246 • Number of events 4 • From first dose of study drug to Day 169	0.81% 2/246 • Number of events 2 • From first dose of study drug to Day 169
General disorders Chills	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	16.7% 2/12 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
General disorders Death	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.99% 2/202 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	1.5% 3/204 • Number of events 3 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.81% 2/246 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
General disorders Fatigue	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
General disorders Generalised oedema	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
General disorders Multiple organ dysfunction syndrome	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	1.8% 1/56 • Number of events 1 • From first dose of study drug to Day 169	1.9% 1/54 • Number of events 1 • From first dose of study drug to Day 169	8.3% 1/12 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	1.2% 3/247 • Number of events 3 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	2.4% 6/246 • Number of events 6 • From first dose of study drug to Day 169
General disorders Non-cardiac chest pain	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
General disorders Pain	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
General disorders Sudden cardiac death	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	8.3% 1/12 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
General disorders Systemic inflammatory response syndrome	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Hepatobiliary disorders Acute hepatic failure	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Hepatobiliary disorders Cholelithiasis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Hepatobiliary disorders Ischaemic hepatitis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Immune system disorders Anaphylactic reaction	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Immune system disorders Hypersensitivity	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Immune system disorders Lung transplant rejection	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.50% 1/202 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Injury, poisoning and procedural complications Brain herniation	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Injury, poisoning and procedural complications Endotracheal intubation complication	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Injury, poisoning and procedural complications Fall	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.99% 2/202 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	8.3% 1/12 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.81% 2/246 • Number of events 2 • From first dose of study drug to Day 169
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Injury, poisoning and procedural complications Head injury	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Injury, poisoning and procedural complications Pancreatic leak	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Injury, poisoning and procedural complications Rib fracture	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Injury, poisoning and procedural complications Stomal hernia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	1.9% 1/54 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Investigations Blood glucose increased	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Investigations ECG signs of myocardial ischaemia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	2.0% 1/51 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Investigations Fibrin D dimer increased	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.50% 1/202 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Investigations Haemoglobin decreased	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.50% 1/202 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Investigations Hepatic enzyme increased	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Investigations Inflammatory marker increased	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Investigations International normalised ratio increased	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Investigations Klebsiella test positive	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	8.3% 1/12 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Metabolism and nutrition disorders Calciphylaxis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.50% 1/202 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Metabolism and nutrition disorders Decreased appetite	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Metabolism and nutrition disorders Dehydration	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.50% 1/202 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Metabolism and nutrition disorders Failure to thrive	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	1.0% 2/198 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Musculoskeletal and connective tissue disorders Compartment syndrome	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Appendix cancer	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myelomonocytic leukaemia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.50% 1/202 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.50% 1/202 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Nervous system disorders Cerebral haemorrhage	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Nervous system disorders Cerebral infarction	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Nervous system disorders Cerebrovascular accident	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	1.0% 2/198 • Number of events 2 • From first dose of study drug to Day 169	0.50% 1/202 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	2.0% 1/51 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	1.9% 1/54 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Nervous system disorders Dementia Alzheimer's type	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Nervous system disorders Depressed level of consciousness	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Nervous system disorders Dizziness	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.50% 1/202 • Number of events 1 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Nervous system disorders Encephalopathy	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.97% 2/206 • Number of events 2 • From first dose of study drug to Day 169	0.98% 2/205 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	8.3% 1/12 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Nervous system disorders Haemorrhage intracranial	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Nervous system disorders Hydrocephalus	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Nervous system disorders Hypoaesthesia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Nervous system disorders Ischaemic stroke	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Nervous system disorders Metabolic encephalopathy	0.00% 0/18 • From first dose of study drug to Day 169	5.6% 1/18 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.81% 2/246 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Nervous system disorders Multiple sclerosis relapse	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Nervous system disorders Seizure	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	5.0% 1/20 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Nervous system disorders Syncope	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.50% 1/202 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	1.5% 3/204 • Number of events 3 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Nervous system disorders Toxic encephalopathy	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Nervous system disorders Transverse sinus thrombosis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	5.0% 1/20 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Nervous system disorders Unresponsive to stimuli	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Product Issues Device occlusion	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Psychiatric disorders Anxiety	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Psychiatric disorders Confusional state	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Psychiatric disorders Delirium	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.50% 1/202 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	2.0% 1/51 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Psychiatric disorders Mental status changes	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	1.0% 2/198 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	1.0% 2/197 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	1.2% 3/246 • Number of events 3 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	2.0% 1/51 • Number of events 1 • From first dose of study drug to Day 169	1.8% 1/56 • Number of events 1 • From first dose of study drug to Day 169	1.9% 1/54 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Surgical and medical procedures Ileostomy closure	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Vascular disorders Arteriosclerosis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Vascular disorders Deep vein thrombosis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	5.0% 1/20 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	2.0% 1/51 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Vascular disorders Distributive shock	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Vascular disorders Embolism venous	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Vascular disorders Haematoma	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Vascular disorders Haemorrhage	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	8.3% 1/12 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Vascular disorders Hypertensive urgency	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.51% 1/197 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Vascular disorders Hypotension	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	5.0% 1/20 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.98% 2/204 • Number of events 2 • From first dose of study drug to Day 169	0.97% 2/206 • Number of events 2 • From first dose of study drug to Day 169	0.98% 2/205 • Number of events 2 • From first dose of study drug to Day 169	2.0% 1/51 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Vascular disorders Hypovolaemic shock	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	5.0% 1/20 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Vascular disorders Orthostatic hypotension	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Vascular disorders Peripheral artery occlusion	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.49% 1/205 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Vascular disorders Shock	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.51% 1/198 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	2.0% 1/51 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Vascular disorders Shock haemorrhagic	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.50% 1/202 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.49% 1/204 • Number of events 1 • From first dose of study drug to Day 169	0.49% 1/206 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Vascular disorders Venous thrombosis	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.40% 1/247 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Vascular disorders Venous thrombosis limb	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	1.9% 1/54 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169

Other adverse events

Measure	Phase 1 Cohort 1: Placebo IV n=18 participants at risk 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 1 (Cohort 1).	Phase 1 Cohort 1: R10933+R10987 2400mg IV n=18 participants at risk 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).	Phase 1 Cohort 1: R10933+R10987 8000mg IV n=20 participants at risk 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).	Phase 2 Cohort 1A: Placebo IV n=198 participants at risk 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).	Phase 2 Cohort 1A: R10933+R10987 2400mg IV n=202 participants at risk 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).	Phase 2 Cohort 1A: R10933+R10987 8000mg IV n=197 participants at risk 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).	Phase 2 Cohort 1: Placebo IV n=204 participants at risk 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 2 (Cohort 1).	Phase 2 Cohort 1: R10933+R10987 2400mg IV n=206 participants at risk 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).	Phase 2 Cohort 1: R10933+R10987 8000mg IV n=205 participants at risk 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 2 (Cohort 1).	Phase 2 Cohort 2: Placebo IV n=51 participants at risk 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).	Phase 2 Cohort 2: R10933+R10987 2400mg IV n=56 participants at risk 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).	Phase 2 Cohort 2: R10933+R10987 8000mg IV n=54 participants at risk 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).	Phase 2 Cohort 3: Placebo IV n=12 participants at risk Participants on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 Cohort 3: R10933+R10987 2400mg IV n=12 participants at risk Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 2 Cohort 3: R10933+R10987 8000mg IV n=11 participants at risk Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).	Phase 3 Cohort 1: Placebo IV n=247 participants at risk 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).	Phase 3 Cohort 1: R10933+R10987 2400mg IV n=246 participants at risk 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).	Phase 3 Cohort 1: R10933+R10987 8000mg IV n=246 participants at risk 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).
Infections and infestations Enterocolitis infectious	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	8.3% 1/12 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations Urinary tract infection	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	8.3% 1/12 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	8.3% 1/12 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Nervous system disorders Peroneal nerve palsy	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	9.1% 1/11 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Psychiatric disorders Delirium	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	8.3% 1/12 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.41% 1/246 • Number of events 1 • From first dose of study drug to Day 169
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	8.3% 1/12 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Vascular disorders Haematoma	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/20 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	8.3% 1/12 • Number of events 2 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169
Infections and infestations COVID-19	0.00% 0/18 • From first dose of study drug to Day 169	0.00% 0/18 • From first dose of study drug to Day 169	5.0% 1/20 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/198 • From first dose of study drug to Day 169	0.00% 0/202 • From first dose of study drug to Day 169	0.00% 0/197 • From first dose of study drug to Day 169	0.00% 0/204 • From first dose of study drug to Day 169	0.00% 0/206 • From first dose of study drug to Day 169	0.00% 0/205 • From first dose of study drug to Day 169	0.00% 0/51 • From first dose of study drug to Day 169	0.00% 0/56 • From first dose of study drug to Day 169	0.00% 0/54 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/12 • From first dose of study drug to Day 169	0.00% 0/11 • From first dose of study drug to Day 169	0.00% 0/247 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169	0.00% 0/246 • From first dose of study drug to Day 169

Additional Information

Clinical Trial Management

Regeneron Pharmaceuticals, Inc

Phone: 844-734-6643

Email: clinicaltrials@regeneron.com

Results disclosure agreements

• Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
• Publication restrictions are in place

Restriction type: OTHER