BLAZE-1: A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04427501
• Collaborator: AbCellera Biologics Inc. (Industry), Shanghai Junshi Bioscience Co., Ltd. (Other)
• Enrollment: 3,290
• Locations: 164
• Arms: 3
• Actual Duration (Months): 17.9
• Patients Per Site: 20.1
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The purpose of this study is to measure how well LY3819253 and LY3832479 work against the virus that causes COVID-19. LY3819253 and LY3832479 will be given to participants with early symptoms of COVID-19. Samples will be taken from the back of the nose to determine how much virus is in the body at various times during the study. Participation could last about 12 weeks and includes one required visit to the study site, with the remainder of assessments performed in the home or by phone.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: LY3819253; Drug: LY3832479; Drug: Placebo	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 3290 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Some treatment arms are open label.
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Placebo-Controlled, Phase 2/3 Study to Evaluate the Efficacy and Safety of LY3819253 and LY3832479 in Participants With Mild to Moderate COVID-19 Illness
• Actual Study Start Date: Jun 17, 2020
• Actual Primary Completion Date: Feb 16, 2021
• Actual Study Completion Date: Dec 14, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3819253 700 mg, 2800 mg, 7000 mg, LY3819253 administered intravenously (IV)	Drug: LY3819253; Administered IV; Other Names: LY-CoV555 Bamlanivimab
Experimental: LY3819253 + LY3832479 350 mg, 700 mg, 2800 mg LY3819253 + 700 mg, 1400 mg, 2800 mg LY3832479 administered IV or subcutaneously (SQ)	Drug: LY3819253; Administered IV; Other Names: LY-CoV555 Bamlanivimab ; Drug: LY3832479; Administered IV; Other Names: LY-CoV016 Etesevimab
Placebo Comparator: Placebo Placebo administered IV	Drug: Placebo; Administered IV

Outcome Measures

Primary Outcome Measures

1. Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization or Death From Any Cause in 2800 mg Bamlanivumab/2800 mg Etesevimab, 700 mg Bamlanivimab/1400mg Etesevimab and Their Placebo Groups [Baseline through Day 29]

   COVID-19 Related Deterioration (yes/no) was defined as a participant experiencing COVID-19-related hospitalization (defined as 24 hours of acute care) or death from any cause by Day 29.

2. Phase 3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold in Arms 350 mg Bamlanivimab/700 mg Etesevimab and Placebo [Day 7]

   SARS-CoV-2 persistent high viral load (yes/no) was defined as ribonuclease P(RP) normalized viral load >=5.27 vs otherwise.

3. Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load [Baseline, Day 11]

   SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), was used for the Day 11 value. If no measurements were available, the Day 11 viral load was treated as missing at random (MAR) in the analysis. Viral load is reported as normalized viral load and is unitless.

4. Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s) [Baseline through Day 85]

   An SAE was defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other different situations will have medical or scientific judgment to determine if they are SAE. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality are reported in the Adverse Events section.

Secondary Outcome Measures

1. Phase 3: Percentage of Participants Demonstrating Symptom Resolution [Day 11]

   Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom resolution (yes/no) is defined as a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache; and a score of 0 or 1 for cough and fatigue on the symptom questionnaire (excluding the loss of appetite and changes in taste and smell symptoms). Missing data were imputed using non-responder imputation (NRI) method.

2. Phase 3: Percentage of Participants Demonstrating Symptom Improvement [Day 11]

   Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom improvement was defined as a participant experiencing both: Symptoms on the symptom questionnaire scored as moderate or severe at baseline are subsequently scored as mild or absent, and symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent. Missing data were imputed using NRI method.

3. Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause [Baseline through Day 85]

   COVID-19 Related Deterioration (yes/no) is defined as a patient experiencing COVID-19-related hospitalization, Emergency Room Visit, or Death from any causes vs otherwise.

4. Phase 3: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load [Baseline, Day 7]

   Change from baseline to Day 7 (±2 days) in SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 7 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 7 visit, but within 2 days (Day 5-Day 9), was used for the Day 7 value. If no measurements are available, the Day 7 viral load was treated as missing at random (MAR) in the analysis. Viral load is reported as normalized viral and is unitless.

5. Phase 3: Time to Sustained Symptom Resolution [Baseline through Day 29]

   Sustained symptom resolution was defined as 2 consecutive assessments with a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache; and a score of 0 or 1 for cough and fatigue on the symptom questionnaire. Participants who did not experience sustained symptom resolution by completion or early discontinuation of study were censored at the date of their last visit during. Additionally, participants who were hospitalized were censored at their date of hospitalization.

6. Phase 3: Time to SARS-CoV-2 Viral Clearance [Baseline through Day 29]

   Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit.

7. Phase 2: Change From Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled With Recent Symptoms Prior to Randomization [Baseline, Day 11]

   SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. This analysis included only participants whose symptoms developed no more than 8 days prior to randomization. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load is missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), will be used for the Day 11 value. If no measurements are available, the Day 11 viral load will be treated as MAR in the analysis.

8. Phase 2: Percentage of Participants Demonstrating Symptom Resolution [Day 11]

   Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom resolution was defined as all symptoms (those scored 0-3) on the symptom questionnaire scored as absent (0). Symptom Resolution (yes/no) was defined as all symptoms (excluding the loss of appetite and changes in taste and smell symptoms) on the symptom questionnaire scored as absent vs otherwise. Missing data were imputed using non-responder imputation (NRI) method.

9. Phase 2: Percentage of Participants Demonstrating Symptom Improvement [Day 11]

   Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom improvement was defined as a participant experiencing both: Symptoms on the symptom questionnaire scored as moderate or severe at baseline are subsequently scored as mild or absent, and Symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent. Missing data were imputed using NRI method.

10. Phase 2, Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Alone and in the Presence of Etesevimab [Day 29 Post-dose]

    (PK): Mean Concentration of Bamlanivimab alone and in the Presence of Etesevimab

11. Phase 2, PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab [Day 29 Post-dose]

    PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab

12. Phase 2: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause [Baseline through Day 85]

    Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related ER Visit, or Death from Any Cause

13. Phase 2: Time to SARS-CoV-2 Viral Clearance [Baseline through Day 29]

    Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Are currently not hospitalized. (Not applicable to participants in treatment arm 22.)

• Have one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion. (Not applicable to participants in treatment arm 22.)

• Must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion

• Are males or females, including pregnant females who agree to contraceptive requirements

• Understand and agree to comply with planned study procedures

• Agree to the collection of nasopharyngeal swabs and venous blood. (Not applicable to participants in treatment arms 20-21.)

• The participant or legally authorized representative give signed informed consent and/or assent

Participants in treatment arms 7-9, 13-14, and 18-21 ONLY

• Are greater than or equal to (≥)18 years of age and must satisfy at least one of the following at the time of screening

• Are pregnant

• Are ≥65 years of age

• Have a body mass index (BMI) ≥35

• Have chronic kidney disease (CKD)

• Have type 1 or type 2 diabetes

• Have immunosuppressive disease

• Are currently receiving immunosuppressive treatment or

• Are ≥55 years of age AND have:

• cardiovascular disease (CVD), OR

• hypertension, OR

• chronic obstructive pulmonary disease (COPD) or other chronic respiratory disease

• Are 12-17 years of age (inclusive) AND satisfy at least one of the following at the time of screening

• Are pregnant

• Have a body mass index (BMI) ≥85th percentile for their age and gender based on CDC growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm

• Have sickle cell disease

• Have congenital or acquired heart disease

• Have neurodevelopmental disorders, for example, cerebral palsy

• Have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)

• Have asthma or reactive airway or other chronic respiratory disease that requires daily medication for control

• Have type 1 or type 2 diabetes

• Have chronic kidney disease

• Have immunosuppressive disease, or

• Are currently receiving immunosuppressive treatment

Participants in treatment arm 22 ONLY

• Are 0 (≥ 32 weeks gestational age AND ≥ 1.5 kilograms [kg]) to 17 years of age (inclusive) AND satisfy at least one of the following risk factors at the time of screening

• Are pregnant

• Have a BMI ≥85th percentile for their age and gender based on CDC growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm

• Have sickle cell disease

• Have congenital or acquired heart disease

• Have neurodevelopmental disorders, for example, cerebral palsy, autism, or Down syndrome (FAIR Health 2020; Spreat et al. 2020)

• Have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)

• Have asthma, cystic fibrosis, reactive airways disease or other chronic respiratory disease that requires daily medication for control

• Have type 1 or type 2 diabetes

• Have chronic kidney disease

• Have immunosuppressive disease, or

• Are currently receiving immunosuppressive treatment, or

• Are less than (<) one year of age.

• Have one or more COVID-19 symptoms

• Shortness of breath/difficulty breathing

• Fever

• Sore throat

• Nausea

• Diarrhea

• Tiredness

• Headache

• New loss of taste

• Nasal congestion/runny nose

• Chills

• Stomachache

• Vomiting

• Cough

• Muscle/body aches and pain

• New loss of smell

• Poor appetite or poor feeding (in babies)

Exclusion Criteria:

• Have oxygen saturation (SpO2) less than or equal to (≤)93 percent (%) on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) less than (<)300, respiratory rate greater than or equal to (≥)30 per minute, heart rate ≥125 per minute due to COVID-19

• Require mechanical ventilation or anticipated impending need for mechanical ventilation due to COVID-19

• Have known allergies to any of the components used in the formulation of the interventions

• Have hemodynamic instability requiring use of pressors within 24 hours of randomization

• Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention

• Have any co-morbidity requiring surgery within <7 days, or that is considered life-threatening within 29 days

• Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study

• Have a history of a positive SARS-CoV-2 test prior to the one serving as eligibility for this study

• Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing

• Have received treatment with a SARS-CoV-2 specific monoclonal antibody

• Have received convalescent COVID-19 plasma treatment

• Have participated in a previous SARS-CoV-2 vaccine study or have received a SARS-CoV-2 vaccine

• Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed

• Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

• Mothers who are breast feeding

Participants in Treatment Arm 22 ONLY

• Have a diagnosis of Multisystem Inflammatory Syndrome in Children (MIS-C) in the opinion of the investigator

• Are currently hospitalized for treatment of COVID-19. Other reasons for hospitalization are acceptable.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233
2	Arizona Clin Trials-Mesa	Mesa	Arizona	United States	85210
3	Perseverance Research Center	Scottsdale	Arizona	United States	85254
4	CRI of Arizona, LLC	Sun City West	Arizona	United States	85375
5	Fiel Family and Sports Medicine PC	Tempe	Arizona	United States	85283
6	Orange Grove Banner Clinic	Tucson	Arizona	United States	85704
7	Arizona Clin Trials-Tucson	Tucson	Arizona	United States	85712
8	Arkansas Children's	Little Rock	Arkansas	United States	72202
9	KLR Business Group, Inc. dba Arkansas Clinical Research	Little Rock	Arkansas	United States	72205
10	Applied Rsch Ctr - Arkansas Inc.	Little Rock	Arkansas	United States	72212
11	Smart Cures Clin Research	Anaheim	California	United States	92806
12	Hope Clinical Research	Canoga Park	California	United States	91303
13	VCT-Covina	Covina	California	United States	91723
14	AMCR Institute	Escondido	California	United States	92025
15	Chemidox Clinical Trials	Lancaster	California	United States	93534
16	Ark Clinical Research	Long Beach	California	United States	90806
17	Long Beach Clinical Trials LLC	Long Beach	California	United States	90806
18	Cedars Sinai Medical Center	Los Angeles	California	United States	90048-5615
19	UCLA Mattel Children's Hospital	Los Angeles	California	United States	90095
20	Central Valley Research, LLC	Modesto	California	United States	95350
21	Catalina Research Institute, LLC	Montclair	California	United States	91763
22	Inland Empire Liver Foundation	Rialto	California	United States	92377
23	Sutter Institute For Medical Research	Sacramento	California	United States	95816
24	Zion Medical Center	San Diego	California	United States	92120
25	Kaiser Permanente - SD Med Ctr	San Diego	California	United States	92123
26	Wolverine Clinical Trials, LLC	Santa Ana	California	United States	92705
27	St. Joe Heritage HC-Santa Rosa	Santa Rosa	California	United States	95405
28	Stanford University Hospital	Stanford	California	United States	94305
29	Mazur, Statner, Dutta, Nathan	Thousand Oaks	California	United States	91360
30	South Bay Clinical Research Institute	Torrance	California	United States	90503
31	Infect Disease Doctors Med Grp	Walnut Creek	California	United States	94598
32	Allianz Research Institute	Westminster	California	United States	92683
33	Future Innovative Treatments LLC	Colorado Springs	Colorado	United States	80907
34	Nemours Childrens Clinic - Delaware Valley of The Nemours Foundation	Wilmington	Delaware	United States	19803
35	Georgetown Univ Sch of Med	Washington	District of Columbia	United States	20007
36	Synergy Healthcare LLC	Bradenton	Florida	United States	34208
37	Holy Cross Hospital Inc.	Fort Lauderdale	Florida	United States	33308
38	I R & Health Center, Inc.	Hialeah	Florida	United States	33012
39	Encore Medical Research	Hollywood	Florida	United States	33021
40	Elixia CRC	Hollywood	Florida	United States	33023
41	University of Florida Jacksonville	Jacksonville	Florida	United States	32209
42	Lakeland Regional Medical Center	Lakeland	Florida	United States	33805
43	Panax Clinical Research	Miami Lakes	Florida	United States	33014
44	Hope Clinical Trials, Inc.	Miami	Florida	United States	33165
45	Miami Cancer Institute at Baptist Health, Inc.	Miami	Florida	United States	33176
46	Bio-Medical Research, LLC	Miami	Florida	United States	33184
47	Clinical Site Partners, LLC d/b/a CSP Miami	Miami	Florida	United States	33186
48	GCPR	Saint Petersburg	Florida	United States	33705
49	Testing Matters Lab	Sunrise	Florida	United States	33325
50	Advent Health Tampa	Tampa	Florida	United States	33613
51	Triple O Research Inst	West Palm Beach	Florida	United States	33407
52	Encore Medical Research - Weston	Weston	Florida	United States	33331
53	Clinical Site Partners, LLC DBA CSP Orlando	Winter Park	Florida	United States	32789
54	Gwinnett Research Inst	Buford	Georgia	United States	30519
55	Paramount Rch Sol - College Pk	College Park	Georgia	United States	30349
56	IACT Health - VHC	Columbus	Georgia	United States	31904
57	Central Georgia Infectious Disease	Macon	Georgia	United States	31201
58	Rophe Adult and Pediatric Medicine	Union City	Georgia	United States	30291
59	Rocky Mountain Clinical Research	Idaho Falls	Idaho	United States	83404
60	Ann & Robert H Lurie Children's Hospital of Chicago	Chicago	Illinois	United States	60611
61	Northwestern University	Chicago	Illinois	United States	60611
62	J H. Stroger Hosp of Cook Co	Chicago	Illinois	United States	60612
63	University of Chi Med Center	Chicago	Illinois	United States	60637
64	Great Lakes Clinical Trials - Andersonville	Chicago	Illinois	United States	60640
65	Franciscan Health Hammond	Dyer	Indiana	United States	46311
66	Qualmedica Research Evansville	Evansville	Indiana	United States	47715
67	Community Hospital South	Indianapolis	Indiana	United States	46227
68	Franciscan St. Francis Health	Indianapolis	Indiana	United States	46237
69	St.Vincent - Indy	Indianapolis	Indiana	United States	46260
70	University of Louisville	Louisville	Kentucky	United States	40202
71	Qualmedica Research, LLC	Owensboro	Kentucky	United States	42301
72	Tandem Clinical Research,LLC	Marrero	Louisiana	United States	70072
73	Imperial Health Urgent Care Center - Moss Bluff	Moss Bluff	Louisiana	United States	70611
74	Nola Research Works, LLC	New Orleans	Louisiana	United States	70125
75	University of Maryland Medical Center	Baltimore	Maryland	United States	21201
76	Institute for Advanced Clinical Trials for Children	Rockville	Maryland	United States	20850
77	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
78	U of MA Mem Med Ctr	Worcester	Massachusetts	United States	01605
79	University of Michigan Health Systems	Ann Arbor	Michigan	United States	48109-5861
80	Great Lakes Research Group, Inc.	Bay City	Michigan	United States	48706
81	Childrens Hospital of Michigan	Detroit	Michigan	United States	48201
82	Henry Ford Hospital	Detroit	Michigan	United States	48202
83	Revive Research Institute	Farmington Hills	Michigan	United States	48334
84	Revival Research Institute	Sterling Heights	Michigan	United States	48312
85	Sky Clinical Prime and Health Wellness Clinic	Fayette	Mississippi	United States	39069
86	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
87	Olive Branch Family Medical Center	Olive Branch	Mississippi	United States	38654
88	Sky Clin Resch - Quinn HC	Ridgeland	Mississippi	United States	39157
89	Bio-Kinetic Clinical Applications, LLC	Springfield	Missouri	United States	65802
90	Be Well Clinical Studies	Lincoln	Nebraska	United States	68516
91	Childrens Endocrine Clinic	Omaha	Nebraska	United States	68114
92	Quality Clinical Research	Omaha	Nebraska	United States	68114
93	Excel Clinical Research	Las Vegas	Nevada	United States	89109
94	Las Vegas Medical Research	Las Vegas	Nevada	United States	89113
95	SG Clinical Research - PC	Las Vegas	Nevada	United States	89128
96	Robert Wood Johnson University Medical School	New Brunswick	New Jersey	United States	08901
97	Holy Name Medical Center	Teaneck	New Jersey	United States	07666
98	Care Access Research - Bronx	Bronx	New York	United States	10456
99	Icahn Sch of Med at Mt. Sinai	New York	New York	United States	10029
100	University of North Carolina	Chapel Hill	North Carolina	United States	27599
101	OnSite Clinical Solutions	Charlotte	North Carolina	United States	28226
102	East Carolina University	Greenville	North Carolina	United States	27834
103	Monroe Biomed Research	Monroe	North Carolina	United States	28112
104	Carteret Medical Group	Morehead City	North Carolina	United States	28557
105	Carolina Research Center, Inc.	Shelby	North Carolina	United States	28150
106	PMG Research of Wilmington	Wilmington	North Carolina	United States	28401
107	Valley Medical Primary Care	Centerville	Ohio	United States	45459
108	Hometown UC and Rch- Cincy	Cincinnati	Ohio	United States	45215
109	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
110	OH State Univ College of Med	Columbus	Ohio	United States	43210
111	Aventiv Research Inc	Columbus	Ohio	United States	43213
112	Urgent Care Specialists, LLC	Columbus	Ohio	United States	43214
113	Remington-Davis, Inc	Columbus	Ohio	United States	43215
114	Urgent Care Specialists, LLC	Dayton	Ohio	United States	45424
115	META Medical Research Institute	Dayton	Ohio	United States	45432
116	Ascension St. John Tulsa OK	Tulsa	Oklahoma	United States	74104
117	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	18901
118	Jefferson Hosp for Neurosci	Philadelphia	Pennsylvania	United States	19107
119	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140
120	Hasbro Children's Hospital	Providence	Rhode Island	United States	02903
121	VITALINK - Anderson	Anderson	South Carolina	United States	29621
122	Carolina Medical Research - Clinton	Clinton	South Carolina	United States	29325
123	VITALINK - Gaffney	Gaffney	South Carolina	United States	29340
124	Carolina Medical Research - Greenville	Greenville	South Carolina	United States	29607
125	VITALINK - Greenville	Greenville	South Carolina	United States	29615
126	VITALINK - Spartanburg	Spartanburg	South Carolina	United States	29303
127	VITALINK - Union	Union	South Carolina	United States	29379
128	Univ Diab & Endo Consult	Chattanooga	Tennessee	United States	37411
129	New Phase Research and Development	Knoxville	Tennessee	United States	37909
130	St Jude Childrens Research Hospital	Memphis	Tennessee	United States	38105
131	Gadolin Research, LLC	Beaumont	Texas	United States	77702
132	Conroe Willis Medical Research	Conroe	Texas	United States	77304
133	Driscoll Children's Hospital	Corpus Christi	Texas	United States	78411
134	Crossroads Clinical Research	Corpus Christi	Texas	United States	78413
135	B S & W Med Center	Dallas	Texas	United States	75246
136	Baylor - Fort Worth	Fort Worth	Texas	United States	76104
137	North Texas Clinical Trials, LLC	Fort Worth	Texas	United States	76104
138	Houston Methodist Research Ins	Houston	Texas	United States	77030
139	Next Level Urgent Care	Houston	Texas	United States	77057
140	Centex-Houston	Houston	Texas	United States	77058
141	Accurate Clinical Management, LLC.	Houston	Texas	United States	77065
142	BioPharma Clinc Site	Houston	Texas	United States	77090
143	Centex-Wesfield	Houston	Texas	United States	77090
144	B S & W Med Center	Irving	Texas	United States	75061
145	Zion Urgent Care Clinic	Katy	Texas	United States	77494
146	BioPharma Family Practice Center McAllen	McAllen	Texas	United States	78501
147	BRCR Medical Center, Inc	McAllen	Texas	United States	78501
148	North Hills Medical Research	North Richland Hills	Texas	United States	76180
149	Bay Area Infectious Diseases Associates	Pasadena	Texas	United States	77505
150	Epic Medical Research	Red Oak	Texas	United States	75154
151	Baylor - Round Rock	Round Rock	Texas	United States	78665
152	Sun Research Institute	San Antonio	Texas	United States	78215
153	Consano Clinical Research, LLC	Shavano Park	Texas	United States	78231
154	APD Clinical Research	Splendora	Texas	United States	77372
155	Baylor Scott and White Medical Center	Temple	Texas	United States	76502
156	Crossroads Clin Rch-Victoria	Victoria	Texas	United States	77901
157	CLS Research Ctr, PLLC	Webster	Texas	United States	77598
158	CARE ID	Annandale	Virginia	United States	22003
159	Virginia Commonwealth University	Richmond	Virginia	United States	23298
160	Evergreen Health Research	Kirkland	Washington	United States	98034
161	West Virginia University Hospital	Morgantown	West Virginia	United States	26506
162	Advanced Clinical Research, LLC	Bayamon		Puerto Rico	00961
163	Dorado Medical Complex Inc	Dorado		Puerto Rico	00646
164	GCM Medical Group, PSC - Hato Rey Site	San Juan		Puerto Rico	00917

Sponsors and Collaborators

• Eli Lilly and Company
• AbCellera Biologics Inc.
• Shanghai Junshi Bioscience Co., Ltd.

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

• Study Protocol - Mar 2, 2021
• Statistical Analysis Plan - Mar 17, 2021

More Information

Additional Information:

• A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness (BLAZE-1)

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT04427501
• Other Study ID Numbers: 17947; J2W-MC-PYAB
• First Posted: Jun 11, 2020
• Last Update Posted: Mar 7, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: COVID-19; Bamlanivimab

Study Results

Participant Flow

Pre-assignment Detail	This study has three parts: Phase 2, Phase 3 and pediatrics addendum. Pediatrics addendum data are going to be reported with end of trial data. All participants in Placebo for Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab are also in Placebo For Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab therefore the two arms are combined to avoid double counting.

Arm/Group Title	Phase 2: Placebo	Phase 2: 700 mg Bamlanivimab	Phase 2: 2800 mg Bamlanivimab	Phase 2: 7000 mg Bamlanivimab	Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab	Phase 3: Placebo	Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab	Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab	Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab	Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Arm/Group Description	Participants received Placebo administered intravenously (IV).	Participants received 700 milligram (mg) bamlanivimab administered IV.	Participants received 2800 mg bamlanivimab administered IV.	Participants received 7000 mg bamlanivimab administered IV.	Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.	Participants received Placebo administered intravenously (IV).	Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.	Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.	Participants received Placebo administered intravenously (IV).	Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
Period Title: Overall Study
STARTED	156	101	107	101	112	776	518	513	141	213
Received at Least One Dose of Study Drug	156	101	107	101	112	776	518	513	141	213
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab	0	0	0	0	0	517	0	0	0	0
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab	0	0	0	0	0	776	0	0	0	0
COMPLETED	141	95	103	98	103	719	485	496	135	207
NOT COMPLETED	15	6	4	3	9	57	33	17	6	6

Baseline Characteristics

Arm/Group Title	Phase 2: Placebo	Phase 2: 700 mg Bamlanivimab	Phase 2: 2800 mg Bamlanivimab	Phase 2: 7000 mg Bamlanivimab	Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab	Phase 3: Placebo	Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab	Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab	Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab	Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab	Total
Arm/Group Description	Participants received Placebo administered intravenously (IV).	Participants received 700 mg bamlanivimab administered IV.	Participants received 2800 mg bamlanivimab administered IV.	Participants received 7000 mg bamlanivimab administered IV.	Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.	Participants received Placebo administered intravenously (IV).	Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.	Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.	Participants received Placebo administered intravenously (IV).	Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.	Total of all reporting groups
Overall Participants	156	101	107	101	112	776	518	513	141	213	2738
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.7 (15.38)	43.5 (16.21)	44.4 (14.61)	45.7 (16.28)	43.9 (16.39)	53.4 (16.52)	54.3 (17.08)	54.5 (16.77)	53.6 (15.70)	52.7 (17.49)	51.9 (16.95)
Sex: Female, Male (Count of Participants)
Female	85 54.5%	63 62.4%	51 47.7%	58 57.4%	58 51.8%	404 52.1%	279 53.9%	265 51.7%	68 48.2%	108 50.7%	1439 52.6%
Male	71 45.5%	38 37.6%	56 52.3%	43 42.6%	54 48.2%	372 47.9%	239 46.1%	248 48.3%	73 51.8%	105 49.3%	1299 47.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	69 44.2%	49 48.5%	47 43.9%	39 38.6%	42 37.5%	226 29.1%	149 28.8%	139 27.1%	36 25.5%	53 24.9%	849 31%
Not Hispanic or Latino	87 55.8%	52 51.5%	60 56.1%	62 61.4%	70 62.5%	548 70.6%	368 71%	373 72.7%	104 73.8%	160 75.1%	1884 68.8%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	2 0.3%	1 0.2%	1 0.2%	1 0.7%	0 0%	5 0.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 1.3%	1 1%	0 0%	0 0%	0 0%	2 0.3%	2 0.4%	3 0.6%	2 1.4%	3 1.4%	15 0.5%
Asian	8 5.1%	1 1%	5 4.7%	3 3%	2 1.8%	33 4.3%	16 3.1%	18 3.5%	6 4.3%	6 2.8%	98 3.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	1 0.9%	0 0%	0 0%	4 0.5%	0 0%	1 0.2%	0 0%	0 0%	6 0.2%
Black or African American	7 4.5%	7 6.9%	7 6.5%	8 7.9%	4 3.6%	61 7.9%	44 8.5%	41 8%	16 11.3%	28 13.1%	223 8.1%
White	133 85.3%	90 89.1%	90 84.1%	89 88.1%	105 93.8%	667 86%	449 86.7%	445 86.7%	116 82.3%	175 82.2%	2359 86.2%
More than one race	1 0.6%	2 2%	1 0.9%	0 0%	0 0%	2 0.3%	1 0.2%	2 0.4%	0 0%	0 0%	9 0.3%
Unknown or Not Reported	5 3.2%	0 0%	3 2.8%	1 1%	1 0.9%	7 0.9%	6 1.2%	3 0.6%	1 0.7%	1 0.5%	28 1%
Region of Enrollment (Count of Participants)
United States	156 100%	101 100%	107 100%	101 100%	112 100%	776 100%	518 100%	513 100%	141 100%	213 100%	2738 100%
SARS-CoV-2 Viral Load (Cycle threshold) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Cycle threshold]	23.79 (7.78)	23.80 (6.55)	24.47 (7.61)	23.42 (6.78)	22.72 (8.01)	24.26 (8.194)	23.98 (8.22)	24.15 (7.28)	24.29 (6.82)	25.62 (7.33)	24.16 (7.75)

Outcome Measures

1. Primary Outcome

Title	Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization or Death From Any Cause in 2800 mg Bamlanivumab/2800 mg Etesevimab, 700 mg Bamlanivimab/1400mg Etesevimab and Their Placebo Groups
Description	COVID-19 Related Deterioration (yes/no) was defined as a participant experiencing COVID-19-related hospitalization (defined as 24 hours of acute care) or death from any cause by Day 29.
Time Frame	Baseline through Day 29

Outcome Measure Data

Analysis Population Description

Phase 3: All randomized participants who received at least one dose of study drug and had COVID-related hospitalization or death from any cause data available in arms Placebo, 2800 mg Bamlanivimab + 2800 mg Etesevimab and 700 mg Bamlanivimab + 1400 mg Etesevimab.

Arm/Group Title	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab	Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab	Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab	Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
Arm/Group Description	Participants received Placebo administered intravenously (IV).	Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.	Participants received Placebo administered intravenously (IV).	Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
Measure Participants	517	518	776	511
Number (95% Confidence Interval) [percentage of participants]	7.0 4.5%	2.1 2.1%	6.8 6.4%	0.8 0.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.30
	Confidence Interval	(2-Sided) 95%; 0.15 to 0.58
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab, Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.12
	Confidence Interval	(2-Sided) 95%; 0.04 to 0.31
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Phase 3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold in Arms 350 mg Bamlanivimab/700 mg Etesevimab and Placebo
Description	SARS-CoV-2 persistent high viral load (yes/no) was defined as ribonuclease P(RP) normalized viral load >=5.27 vs otherwise.
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

Phase 3: All randomized participants who received at least one dose of study drug and had non-missing viral load values in arms Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab and 350 mg Bamlanivimab + 700 mg Etesevimab

Arm/Group Title	Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab	Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Arm/Group Description	Participants received Placebo administered intravenously (IV).	Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
Measure Participants	141	213
Number (95% Confidence Interval) [percentage of participants]	34.8 22.3%	10.8 10.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.23
	Confidence Interval	(2-Sided) 95%; 0.13 to 0.40
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load
Description	SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), was used for the Day 11 value. If no measurements were available, the Day 11 viral load was treated as missing at random (MAR) in the analysis. Viral load is reported as normalized viral load and is unitless.
Time Frame	Baseline, Day 11

Outcome Measure Data

Analysis Population Description

Phase 2: All randomized participants who received at least one dose of study drug and had a baseline and day 11 viral load value.

Arm/Group Title	Part A: Placebo	Phase 2: 700 mg Bamlanivimab	Phase 2: 2800 mg Bamlanivimab	Phase 2: 7000 mg Bamlanivimab	Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Arm/Group Description	Participants received Placebo administered intravenously (IV).	Participants received 700 mg bamlanivimab administered IV.	Participants received 2800 mg bamlanivimab administered IV.	Participants received 7000 mg bamlanivimab administered IV.	Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
Measure Participants	146	100	103	95	102
Least Squares Mean (Standard Error) [unitless]	-3.80 (0.141)	-3.72 (0.170)	-4.08 (0.168)	-3.49 (0.175)	-4.37 (0.169)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.6921
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.09
	Confidence Interval	(2-Sided) 95%; -0.35 to 0.52
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.221
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2110
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.27
	Confidence Interval	(2-Sided) 95%; -0.71 to 0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.219
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1630
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.31
	Confidence Interval	(2-Sided) 95%; -0.13 to 0.76
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.225
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0099
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.57
	Confidence Interval	(2-Sided) 95%; -1.00 to -0.14
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.220
	Estimation Comments

4. Primary Outcome

Title	Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s)
Description	An SAE was defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other different situations will have medical or scientific judgment to determine if they are SAE. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality are reported in the Adverse Events section.
Time Frame	Baseline through Day 85

Outcome Measure Data

Analysis Population Description

Phase 2: All randomized participants who received at least one dose of study drug.

Arm/Group Title	Phase 2: Placebo	Phase 2: 700 mg Bamlanivimab	Phase 2: 2800 mg Bamlanivimab	Phase 2: 7000 mg Bamlanivimab	Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Arm/Group Description	Participants received Placebo administered intravenously (IV).	Participants received 700 mg bamlanivimab administered IV.	Participants received 2800 mg bamlanivimab administered IV.	Participants received 7000 mg bamlanivimab administered IV.	Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
Measure Participants	156	101	107	101	112
Number [percentage of participants]	0.6 0.4%	0 0%	0 0%	0 0%	0.9 0.8%

5. Secondary Outcome

Title	Phase 3: Percentage of Participants Demonstrating Symptom Resolution
Description	Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom resolution (yes/no) is defined as a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache; and a score of 0 or 1 for cough and fatigue on the symptom questionnaire (excluding the loss of appetite and changes in taste and smell symptoms). Missing data were imputed using non-responder imputation (NRI) method.
Time Frame	Day 11

Outcome Measure Data

Analysis Population Description

Phase 3: All randomized participants who received at least one dose of study drug and had non-missing Symptom Resolution values

Arm/Group Title	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab	Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab	Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab	Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab	Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab	Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Arm/Group Description	Participants received Placebo administered intravenously (IV).	Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.	Participants received Placebo administered intravenously (IV).	Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.	Participants received Placebo administered intravenously (IV).	Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
Measure Participants	499	508	774	510	141	213
Number (95% Confidence Interval) [percentage of participants]	52.1 33.4%	61.2 60.6%	50.9 47.6%	61.8 61.2%	51.8 46.3%	63.8 8.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.45
	Confidence Interval	(2-Sided) 95%; 1.13 to 1.86
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab, Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.56
	Confidence Interval	(2-Sided) 95%; 1.24 to 1.95
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.64
	Confidence Interval	(2-Sided) 95%; 1.06 to 2.53
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Phase 3: Percentage of Participants Demonstrating Symptom Improvement
Description	Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom improvement was defined as a participant experiencing both: Symptoms on the symptom questionnaire scored as moderate or severe at baseline are subsequently scored as mild or absent, and symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent. Missing data were imputed using NRI method.
Time Frame	Day 11

Outcome Measure Data

Analysis Population Description

Phase 3: All randomized participants who received at least one dose of study drug and had non-missing Symptom Improvement values

Arm/Group Title	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab	Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab	Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab	Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab	Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab	Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Arm/Group Description	Participants received Placebo administered intravenously (IV).	Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.	Participants received Placebo administered intravenously (IV).	Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.	Participants received Placebo administered intravenously (IV).	Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
Measure Participants	499	508	774	510	141	213
Number (95% Confidence Interval) [percentage of participants]	40.9 26.2%	51.0 50.5%	40.1 37.5%	52.7 52.2%	38.3 34.2%	54.0 7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.50
	Confidence Interval	(2-Sided) 95%; 1.17 to 1.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab, Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.67
	Confidence Interval	(2-Sided) 95%; 1.33 to 2.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.88
	Confidence Interval	(2-Sided) 95%; 1.22 to 2.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause
Description	COVID-19 Related Deterioration (yes/no) is defined as a patient experiencing COVID-19-related hospitalization, Emergency Room Visit, or Death from any causes vs otherwise.
Time Frame	Baseline through Day 85

Outcome Measure Data

Analysis Population Description

Phase 3: All randomized participants who received at least one dose of study drug and had COVID-related hospitalization, COVID-Related Emergency Room (ER) Visit, or death from any cause data available.

Arm/Group Title	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab	Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab	Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab	Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab	Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab	Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Arm/Group Description	Participants received Placebo administered intravenously (IV).	Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.	Participants received Placebo administered intravenously (IV).	Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.	Participants received Placebo administered intravenously (IV).	Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
Measure Participants	517	518	716	511	141	231
Number (95% Confidence Interval) [percentage of participants]	7.2 4.6%	2.5 2.5%	7.0 6.5%	1.2 1.2%	4.3 3.8%	0.9 0.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.34
	Confidence Interval	(2-Sided) 95%; 0.18 to 0.64
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab, Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.17
	Confidence Interval	(2-Sided) 95%; 0.07 to 0.38
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.25
	Confidence Interval	(2-Sided) 95%; 0.06 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Phase 3: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Description	Change from baseline to Day 7 (±2 days) in SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 7 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 7 visit, but within 2 days (Day 5-Day 9), was used for the Day 7 value. If no measurements are available, the Day 7 viral load was treated as missing at random (MAR) in the analysis. Viral load is reported as normalized viral and is unitless.
Time Frame	Baseline, Day 7

Outcome Measure Data

Analysis Population Description

Phase 3: All randomized participants who received at least one dose of study drug and had a baseline and day 7 viral load value.

Arm/Group Title	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab	Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab	Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab	Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab	Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab	Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Arm/Group Description	Participants received Placebo administered intravenously (IV).	Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.	Participants received Placebo administered intravenously (IV).	Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.	Participants received Placebo administered intravenously (IV).	Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
Measure Participants	403	455	614	399	122	194
Least Squares Mean (Standard Error) [unitless]	-2.46 (0.095)	-3.66 (0.090)	-2.56 (0.079)	-3.65 (0.098)	-2.51 (0.185)	-3.50 (0.147)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0000000
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.20
	Confidence Interval	(2-Sided) 95%; -1.46 to -0.94
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab, Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0000000
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.09
	Confidence Interval	(2-Sided) 95%; -1.34 to -0.85
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.00003777
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.99
	Confidence Interval	(2-Sided) 95%; -1.45 to -0.52
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Phase 3: Time to Sustained Symptom Resolution
Description	Sustained symptom resolution was defined as 2 consecutive assessments with a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache; and a score of 0 or 1 for cough and fatigue on the symptom questionnaire. Participants who did not experience sustained symptom resolution by completion or early discontinuation of study were censored at the date of their last visit during. Additionally, participants who were hospitalized were censored at their date of hospitalization.
Time Frame	Baseline through Day 29

Outcome Measure Data

Analysis Population Description

Phase 3: All randomized participants (including censored) who received at least one dose of study drug and who had at least one post-baseline symptom measurement. Participants censored: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab = 121, 2800 mg Bamlanivimab + 2800 mg Etesevimab = 88, Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab= 226, 700 mg Bamlanivimab + 1400 mg Etesevimab= 128, Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab=44, 350 mg Bamlanivimab + 700 mg Etesevimab=43

Arm/Group Title	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab	Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab	Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab	Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab	Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab	Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Arm/Group Description	Participants received Placebo administered intravenously (IV).	Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.	Participants received Placebo administered intravenously (IV).	Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.	Participants received Placebo administered intravenously (IV).	Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
Measure Participants	499	508	774	510	141	213
Median (95% Confidence Interval) [Days]	9.00	8.00	9.00	8.00	9.00	6.00

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	Stratified Log-rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.213
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab, Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.130
	Comments
	Method	Stratified Log-rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.111
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.012
	Comments
	Method	Stratified Log-rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.380
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Phase 3: Time to SARS-CoV-2 Viral Clearance
Description	Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit.
Time Frame	Baseline through Day 29

Outcome Measure Data

Analysis Population Description

Phase 3: All randomized participants (Including censored) who received at least 1 dose of study drug and had at least 1 post-baseline viral load measurement. Censored participants: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab = 358, 2800 mg Bamlanivimab + 2800 mg Etesevimab = 325, Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab =530, 700 mg Bamlanivimab + 1400 mg Etesevimab= 326, Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab=95, 350 mg Bamlanivimab + 700 mg Etesevimab=114

Arm/Group Title	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab	Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab	Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab	Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab	Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab	Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Arm/Group Description	Participants received Placebo administered intravenously (IV).	Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.	Participants received Placebo administered intravenously (IV).	Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.	Participants received Placebo administered intravenously (IV).	Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
Measure Participants	499	508	774	510	141	213
Median (95% Confidence Interval) [Days]	NA	NA	NA	NA	NA	NA

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	Stratified Log-rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.355
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.033
	Comments
	Method	Stratified Log-rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.237
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.017
	Comments
	Method	Stratified Log-rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.521
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Phase 2: Change From Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled With Recent Symptoms Prior to Randomization
Description	SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. This analysis included only participants whose symptoms developed no more than 8 days prior to randomization. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load is missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), will be used for the Day 11 value. If no measurements are available, the Day 11 viral load will be treated as MAR in the analysis.
Time Frame	Baseline, Day 11

Outcome Measure Data

Analysis Population Description

Phase 2: All randomized participants who received at least one dose of study drug and had baseline and post-baseline viral load value. Participants enrolled with recent symptoms prior to randomization.

Arm/Group Title	Phase 2: Placebo	Phase 2: 700 mg Bamlanivimab	Phase 2: 2800 mg Bamlanivimab	Phase 2: 7000 mg Bamlanivimab	Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Arm/Group Description	Participants received Placebo administered intravenously (IV).	Participants received 700 mg bamlanivimab administered IV.	Participants received 2800 mg bamlanivimab administered IV.	Participants received 7000 mg bamlanivimab administered IV.	Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
Measure Participants	123	84	88	81	95
Least Squares Mean (Standard Error) [unitless]	-4.03 (0.155)	-3.87 (0.187)	-4.20 (0.184)	-3.65 (0.191)	-4.46 (0.178)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.499
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.16
	Confidence Interval	(2-Sided) 95%; -0.31 to 0.64
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.243
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.492
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.17
	Confidence Interval	(2-Sided) 95%; -0.64 to 0.31
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.241
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.125
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.38
	Confidence Interval	(2-Sided) 95%; -0.11 to 0.86
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.246
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.069
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.43
	Confidence Interval	(2-Sided) 95%; -0.89 to 0.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.236
	Estimation Comments

12. Secondary Outcome

Title	Phase 2: Percentage of Participants Demonstrating Symptom Resolution
Description	Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom resolution was defined as all symptoms (those scored 0-3) on the symptom questionnaire scored as absent (0). Symptom Resolution (yes/no) was defined as all symptoms (excluding the loss of appetite and changes in taste and smell symptoms) on the symptom questionnaire scored as absent vs otherwise. Missing data were imputed using non-responder imputation (NRI) method.
Time Frame	Day 11

Outcome Measure Data

Analysis Population Description

Phase 2: All randomized participants who received at least one dose of study drug and had non-missing Symptom Resolution values

Arm/Group Title	Phase 2: Placebo	Phase 2: 700 mg Bamlanivimab	Phase 2: 2800 mg Bamlanivimab	Phase 2: 7000 mg Bamlanivimab	Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Arm/Group Description	Participants received Placebo administered intravenously (IV).	Participants received 700 mg bamlanivimab administered IV.	Participants received 2800 mg bamlanivimab administered IV.	Participants received 7000 mg bamlanivimab administered IV.	Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
Measure Participants	152	101	107	101	109
Number (95% Confidence Interval) [percentage of participants]	36.8 23.6%	50.5 50%	40.2 37.6%	43.6 43.2%	45.9 41%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.034
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.74
	Confidence Interval	(2-Sided) 95%; 1.04 to 2.90
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.594
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.15
	Confidence Interval	(2-Sided) 95%; 0.69 to 1.91
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.291
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.32
	Confidence Interval	(2-Sided) 95%; 0.79 to 2.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.143
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.45
	Confidence Interval	(2-Sided) 95%; 0.88 to 2.40
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Secondary Outcome

Title	Phase 2: Percentage of Participants Demonstrating Symptom Improvement
Description	Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom improvement was defined as a participant experiencing both: Symptoms on the symptom questionnaire scored as moderate or severe at baseline are subsequently scored as mild or absent, and Symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent. Missing data were imputed using NRI method.
Time Frame	Day 11

Outcome Measure Data

Analysis Population Description

Phase 2: All randomized participants who received at least one dose of study drug and had non-missing Symptom Improvement values

Arm/Group Title	Phase 2: Placebo	Phase 2: 700 mg Bamlanivimab	Phase 2: 2800 mg Bamlanivimab	Phase 2: 7000 mg Bamlanivimab	Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Arm/Group Description	Participants received Placebo administered intravenously (IV).	Participants received 700 mg bamlanivimab administered IV.	Participants received 2800 mg bamlanivimab administered IV.	Participants received 7000 mg bamlanivimab administered IV.	Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV..
Measure Participants	152	101	107	101	109
Number (95% Confidence Interval) [percentage of participants]	43.4 27.8%	59.4 58.8%	44.9 42%	58.4 57.8%	53.2 47.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.014
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.89
	Confidence Interval	(2-Sided) 95%; 1.14 to 3.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.828
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 95%; 0.64 to 1.74
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.022
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.82
	Confidence Interval	(2-Sided) 95%; 1.09 to 3.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.119
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.48
	Confidence Interval	(2-Sided) 95%; 0.90 to 2.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

14. Secondary Outcome

Title	Phase 2, Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Alone and in the Presence of Etesevimab
Description	(PK): Mean Concentration of Bamlanivimab alone and in the Presence of Etesevimab
Time Frame	Day 29 Post-dose

Outcome Measure Data

Analysis Population Description

Phase 2: All randomized participants who received a complete dose of Bamlanivimab (for Bamlanivimab only arms) or Bamlanivimab in the Presence of Etesevimab (for Bamlanivimab + Etesevimab) and had at least 1 post-dose PK sample.

Arm/Group Title	Phase 2: 700 mg Bamlanivimab	Phase 2: 2800 mg Bamlanivimab	Phase 2: 7000 mg Bamlanivimab	Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Arm/Group Description	Participants received 700 mg bamlanivimab (alone) administered IV.	Participants received 2800 mg bamlanivimab (alone) administered IV.	Participants received 7000 mg bamlanivimab (alone) administered IV..	Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
Measure Participants	80	89	86	92
Geometric Mean (Geometric Coefficient of Variation) [Microgram/milliliter (µg/mL)]	25.6 (42.2)	83.8 (50.0)	227 (39.6)	100 (46.1)

15. Secondary Outcome

Title	Phase 2, PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab
Description	PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab
Time Frame	Day 29 Post-dose

Outcome Measure Data

Analysis Population Description

Phase 2: All randomized participants who received a complete dose of Etesevimab in the Presence of Bamlanivimab and had at least 1 post-dose PK sample.

Arm/Group Title	Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Arm/Group Description	Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
Measure Participants	92
Geometric Mean (Geometric Coefficient of Variation) [µg/mL]	243 (35.1)

16. Secondary Outcome

Title	Phase 2: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause
Description	Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related ER Visit, or Death from Any Cause
Time Frame	Baseline through Day 85

Outcome Measure Data

Analysis Population Description

Phase 2: All participants who received at least one dose of study drug.

Arm/Group Title	Part A: Placebo	Phase 2: 700 mg Bamlanivimab	Phase 2: 2800 mg Bamlanivimab	Phase 2: 7000 mg Bamlanivimab	Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Arm/Group Description	Participants received Placebo administered intravenously (IV).	Participants received 700 mg bamlanivimab administered IV.	Participants received 2800 mg bamlanivimab administered IV.	Participants received 7000 mg bamlanivimab administered IV.	Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
Measure Participants	156	101	107	101	112
Number (95% Confidence Interval) [percentage of participants]	5.8 3.7%	1.0 1%	1.9 1.8%	2.0 2%	0.9 0.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.098
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.23
	Confidence Interval	(2-Sided) 95%; 0.04 to 1.31
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.165
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.37
	Confidence Interval	(2-Sided) 95%; 0.09 to 1.51
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.191
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.39
	Confidence Interval	(2-Sided) 95%; 0.10 to 1.60
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.075
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.21
	Confidence Interval	(2-Sided) 95%; 0.04 to 1.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

17. Secondary Outcome

Title	Phase 2: Time to SARS-CoV-2 Viral Clearance
Description	Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit.
Time Frame	Baseline through Day 29

Outcome Measure Data

Analysis Population Description

Phase 2: All randomized participants (including censored) who received at least one dose of study drug and had at least one post-baseline viral load measurement. Censored: Part A: Placebo= 68, Phase 2: 700 mg Bamlanivimab=39, Phase 2: 2800 mg Bamlanivimab=40, Phase 2: 7000 mg Bamlanivimab=42 and Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab=45

Arm/Group Title	Phase 2: Placebo	Phase 2: 700 mg Bamlanivimab	Phase 2: 2800 mg Bamlanivimab	Phase 2: 7000 mg Bamlanivimab	Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Arm/Group Description	Participants received Placebo administered intravenously (IV).	Participants received 700 mg bamlanivimab administered IV.	Participants received 2800 mg bamlanivimab administered IV.	Participants received 7000 mg bamlanivimab administered IV..	Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV..
Measure Participants	152	101	107	101	109
Median (95% Confidence Interval) [Days]	24	25.00	23.00	25.00	21.00

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.616
	Comments
	Method	Stratified Log-rank
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.281
	Comments
	Method	Stratified Log-rank
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.815
	Comments
	Method	Stratified Log-rank
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab, Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.334
	Comments
	Method	Stratified Log-rank
	Comments

Adverse Events

Time Frame	Baseline Up To 85 Days
Adverse Event Reporting Description	All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Arm/Group Title	Phase 2: Placebo		Phase 2: 700 mg Bamlanivimab		Phase 2: 2800 mg Bamlanivimab		Phase 2: 7000 mg Bamlanivimab		Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab		Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab		Phase 3: Placebo		Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab		Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab		Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Arm/Group Description	Participants received Placebo administered intravenously (IV).		Participants received 700 mg bamlanivimab administered IV.		Participants received 2800 mg bamlanivimab administered IV.		Participants received 7000 mg bamlanivimab administered IV.		Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.		Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.		Participants received Placebo administered intravenously (IV).		Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.		Participants received Placebo administered intravenously (IV).		Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
All Cause Mortality
	Phase 2: Placebo		Phase 2: 700 mg Bamlanivimab		Phase 2: 2800 mg Bamlanivimab		Phase 2: 7000 mg Bamlanivimab		Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab		Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab		Phase 3: Placebo		Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab		Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab		Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/156 (0%)		0/101 (0%)		0/107 (0%)		0/101 (0%)		0/112 (0%)		0/518 (0%)		15/776 (1.9%)		0/513 (0%)		0/141 (0%)		0/213 (0%)
Serious Adverse Events
	Phase 2: Placebo		Phase 2: 700 mg Bamlanivimab		Phase 2: 2800 mg Bamlanivimab		Phase 2: 7000 mg Bamlanivimab		Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab		Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab		Phase 3: Placebo		Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab		Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab		Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/156 (0.6%)		2/101 (2%)		0/107 (0%)		0/101 (0%)		1/112 (0.9%)		10/518 (1.9%)		8/776 (1%)		16/513 (3.1%)		4/141 (2.8%)		1/213 (0.5%)
Cardiac disorders
Acute myocardial infarction	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Angina pectoris	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	2	0/141 (0%)	0	0/213 (0%)	0
Angina unstable	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Atrial fibrillation	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Atrial flutter	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Cardiac arrest	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	1/141 (0.7%)	1	0/213 (0%)	0
Coronary artery disease	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Myocardial infarction	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	1/141 (0.7%)	1	0/213 (0%)	0
Ventricular extrasystoles	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Eye disorders
Macular oedema	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Retinal vein occlusion	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Gastrointestinal disorders
Abdominal pain	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Colitis	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Duodenitis	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Gastritis	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Gastrointestinal haemorrhage	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Gastrooesophageal reflux disease	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Intestinal obstruction	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Intussusception	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Small intestinal obstruction	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
General disorders
Chest pain	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	1/141 (0.7%)	1	0/213 (0%)	0
Sudden death	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Hepatobiliary disorders
Cholecystitis acute	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Infections and infestations
Covid-19 pneumonia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	1/141 (0.7%)	1	0/213 (0%)	0
Localised infection	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Medical device site joint infection	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Perirectal abscess	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Sialoadenitis	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Urinary tract infection	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	1/112 (0.9%)	1	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Injury, poisoning and procedural complications
Bone contusion	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	1/141 (0.7%)	1	0/213 (0%)	0
Concussion	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	1/141 (0.7%)	1	0/213 (0%)	0
Femur fracture	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	1/213 (0.5%)	1
Foot fracture	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Hip fracture	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	1/141 (0.7%)	1	0/213 (0%)	0
Injury	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Road traffic accident	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Toxicity to various agents	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Investigations
Catheterisation cardiac	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Metabolism and nutrition disorders
Dehydration	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Diabetic ketoacidosis	0/156 (0%)	0	1/101 (1%)	1	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Hyperglycaemia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Hyponatraemia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma	0/156 (0%)	0	1/101 (1%)	1	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Lung neoplasm malignant	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Nervous system disorders
Syncope	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Renal and urinary disorders
Acute kidney injury	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Reproductive system and breast disorders
Heavy menstrual bleeding	0/85 (0%)	0	0/63 (0%)	0	0/51 (0%)	0	0/58 (0%)	0	0/58 (0%)	0	1/279 (0.4%)	1	0/404 (0%)	0	0/265 (0%)	0	0/68 (0%)	0	0/108 (0%)	0
Uterine mass	0/85 (0%)	0	0/63 (0%)	0	0/51 (0%)	0	0/58 (0%)	0	0/58 (0%)	0	0/279 (0%)	0	1/404 (0.2%)	1	0/265 (0%)	0	0/68 (0%)	0	0/108 (0%)	0
Respiratory, thoracic and mediastinal disorders
Asthma	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Epistaxis	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Hypoxia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Pleural effusion	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	1/141 (0.7%)	1	0/213 (0%)	0
Respiratory arrest	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	1/141 (0.7%)	1	0/213 (0%)	0
Vascular disorders
Arterial occlusive disease	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Other (Not Including Serious) Adverse Events
	Phase 2: Placebo		Phase 2: 700 mg Bamlanivimab		Phase 2: 2800 mg Bamlanivimab		Phase 2: 7000 mg Bamlanivimab		Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab		Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab		Phase 3: Placebo		Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab		Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab		Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	44/156 (28.2%)		29/101 (28.7%)		26/107 (24.3%)		24/101 (23.8%)		23/112 (20.5%)		72/518 (13.9%)		92/776 (11.9%)		61/513 (11.9%)		17/141 (12.1%)		14/213 (6.6%)
Blood and lymphatic system disorders
Anaemia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	4/513 (0.8%)	4	0/141 (0%)	0	2/213 (0.9%)	2
Leukopenia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Lymphopenia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Microcytic anaemia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	1/141 (0.7%)	1	0/213 (0%)	0
Monocytopenia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Neutropenia	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	2/513 (0.4%)	2	0/141 (0%)	0	0/213 (0%)	0
Thrombocytopenia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Thrombocytosis	0/156 (0%)	0	1/101 (1%)	1	1/107 (0.9%)	1	0/101 (0%)	0	1/112 (0.9%)	1	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Cardiac disorders
Acute myocardial infarction	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Angina pectoris	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Atrial fibrillation	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	1/141 (0.7%)	1	0/213 (0%)	0
Palpitations	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Tachycardia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Ventricular extrasystoles	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Ventricular tachycardia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Ear and labyrinth disorders
Ear pain	0/156 (0%)	0	1/101 (1%)	1	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Vertigo	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	1/101 (1%)	1	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Eye disorders
Blepharitis	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Blepharospasm	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	1/101 (1%)	1	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Cataract	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	2/513 (0.4%)	2	0/141 (0%)	0	0/213 (0%)	0
Cataract nuclear	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Diplopia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Eye pain	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Eye paraesthesia	0/156 (0%)	0	1/101 (1%)	1	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Eyelids pruritus	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Photophobia	0/156 (0%)	0	1/101 (1%)	1	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Retinal vein occlusion	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Retinopathy hypertensive	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Vision blurred	0/156 (0%)	0	1/101 (1%)	1	0/107 (0%)	0	1/101 (1%)	1	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Visual impairment	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Vitreous haemorrhage	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Xanthopsia	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Gastrointestinal disorders
Abdominal discomfort	0/156 (0%)	0	1/101 (1%)	1	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Abdominal distension	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	1/101 (1%)	1	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Abdominal pain	1/156 (0.6%)	1	0/101 (0%)	0	1/107 (0.9%)	1	1/101 (1%)	1	1/112 (0.9%)	1	1/518 (0.2%)	1	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Abdominal pain lower	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Abdominal pain upper	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	2/776 (0.3%)	2	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Aphthous ulcer	0/156 (0%)	0	0/101 (0%)	0	1/107 (0.9%)	1	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Colitis	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Constipation	1/156 (0.6%)	2	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	1/112 (0.9%)	1	1/518 (0.2%)	1	1/776 (0.1%)	1	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Diarrhoea	7/156 (4.5%)	7	1/101 (1%)	1	1/107 (0.9%)	1	5/101 (5%)	5	1/112 (0.9%)	1	2/518 (0.4%)	2	3/776 (0.4%)	3	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Dry mouth	0/156 (0%)	0	0/101 (0%)	0	1/107 (0.9%)	1	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Dyspepsia	0/156 (0%)	0	1/101 (1%)	1	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	2/518 (0.4%)	2	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Dysphagia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Frequent bowel movements	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Gastric ulcer	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	2/513 (0.4%)	2	0/141 (0%)	0	0/213 (0%)	0
Gastritis	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Gastritis haemorrhagic	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Gastrointestinal motility disorder	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Gastrooesophageal reflux disease	0/156 (0%)	0	2/101 (2%)	2	0/107 (0%)	0	1/101 (1%)	1	2/112 (1.8%)	2	3/518 (0.6%)	3	1/776 (0.1%)	1	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Haematemesis	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Haemorrhoids thrombosed	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Hiatus hernia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	1/213 (0.5%)	1
Hypoaesthesia oral	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Irritable bowel syndrome	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Melaena	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Mouth ulceration	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Nausea	7/156 (4.5%)	8	3/101 (3%)	3	4/107 (3.7%)	4	4/101 (4%)	4	4/112 (3.6%)	5	5/518 (1%)	5	5/776 (0.6%)	5	3/513 (0.6%)	4	0/141 (0%)	0	0/213 (0%)	0
Oesophageal ulcer	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Oral disorder	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	1/112 (0.9%)	1	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Paraesthesia oral	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Retching	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Stomatitis	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	1/101 (1%)	1	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Swollen tongue	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Tongue ulceration	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	1/141 (0.7%)	1	0/213 (0%)	0
Toothache	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Vomiting	4/156 (2.6%)	4	1/101 (1%)	1	3/107 (2.8%)	4	1/101 (1%)	1	1/112 (0.9%)	1	1/518 (0.2%)	1	2/776 (0.3%)	2	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
General disorders
Asthenia	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	1/141 (0.7%)	1	0/213 (0%)	0
Chest discomfort	1/156 (0.6%)	1	0/101 (0%)	0	1/107 (0.9%)	1	1/101 (1%)	1	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Chest pain	0/156 (0%)	0	1/101 (1%)	1	1/107 (0.9%)	1	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Chills	0/156 (0%)	0	0/101 (0%)	0	1/107 (0.9%)	1	3/101 (3%)	3	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Extravasation	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	3/112 (2.7%)	3	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Fatigue	0/156 (0%)	0	0/101 (0%)	0	1/107 (0.9%)	1	2/101 (2%)	2	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	1/141 (0.7%)	1	0/213 (0%)	0
Feeling abnormal	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	1/101 (1%)	1	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Infusion site pain	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Infusion site rash	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Injection site extravasation	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	2/776 (0.3%)	2	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Nodule	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Non-cardiac chest pain	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Oedema peripheral	0/156 (0%)	0	1/101 (1%)	1	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Pain	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Pyrexia	0/156 (0%)	0	1/101 (1%)	1	2/107 (1.9%)	2	1/101 (1%)	1	1/112 (0.9%)	1	3/518 (0.6%)	3	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Swelling face	0/156 (0%)	0	1/101 (1%)	1	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Thirst	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Xerosis	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Immune system disorders
Drug hypersensitivity	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	2/513 (0.4%)	2	0/141 (0%)	0	0/213 (0%)	0
Hypersensitivity	1/156 (0.6%)	1	1/101 (1%)	1	1/107 (0.9%)	1	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Seasonal allergy	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Infections and infestations
Appendicitis	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Bacteraemia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Bronchitis	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Candida infection	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Cellulitis	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Conjunctivitis	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Covid-19	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	2/776 (0.3%)	2	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Ear infection	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	1/112 (0.9%)	1	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Epididymitis	0/71 (0%)	0	0/38 (0%)	0	0/56 (0%)	0	0/43 (0%)	0	0/54 (0%)	0	0/239 (0%)	0	1/372 (0.3%)	1	0/248 (0%)	0	0/73 (0%)	0	0/105 (0%)	0
Eye infection	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Fungal infection	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	2/776 (0.3%)	2	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Gangrene	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Gastroenteritis	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	1/141 (0.7%)	1	0/213 (0%)	0
Herpes simplex	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	1/101 (1%)	1	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Herpes virus infection	0/156 (0%)	0	0/101 (0%)	0	1/107 (0.9%)	1	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Herpes zoster	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	1/112 (0.9%)	1	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Localised infection	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Nasopharyngitis	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Onychomycosis	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Otitis media	2/156 (1.3%)	2	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Pelvic inflammatory disease	1/85 (1.2%)	1	0/63 (0%)	0	0/51 (0%)	0	0/58 (0%)	0	0/58 (0%)	0	0/279 (0%)	0	0/404 (0%)	0	0/265 (0%)	0	0/68 (0%)	0	0/108 (0%)	0
Pharyngitis	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	1/101 (1%)	1	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Pilonidal cyst	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	1/141 (0.7%)	1	0/213 (0%)	0
Pneumonia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	1/776 (0.1%)	1	0/513 (0%)	0	1/141 (0.7%)	1	0/213 (0%)	0
Pneumonia bacterial	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Pneumonia viral	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Pyelonephritis	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Respiratory tract infection viral	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Sinusitis	3/156 (1.9%)	3	0/101 (0%)	0	0/107 (0%)	0	1/101 (1%)	1	0/112 (0%)	0	1/518 (0.2%)	2	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Skin infection	0/156 (0%)	0	1/101 (1%)	1	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Tonsillitis	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	1/101 (1%)	1	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Tooth abscess	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Tooth infection	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	1/776 (0.1%)	1	1/513 (0.2%)	1	1/141 (0.7%)	1	0/213 (0%)	0
Urinary tract infection	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	2/101 (2%)	2	1/112 (0.9%)	2	3/518 (0.6%)	3	2/776 (0.3%)	2	1/513 (0.2%)	1	3/141 (2.1%)	3	2/213 (0.9%)	2
Vaginal infection	0/85 (0%)	0	0/63 (0%)	0	0/51 (0%)	0	0/58 (0%)	0	0/58 (0%)	0	1/279 (0.4%)	1	1/404 (0.2%)	1	0/265 (0%)	0	0/68 (0%)	0	0/108 (0%)	0
Vulvovaginal mycotic infection	0/85 (0%)	0	0/63 (0%)	0	0/51 (0%)	0	0/58 (0%)	0	0/58 (0%)	0	0/279 (0%)	0	0/404 (0%)	0	0/265 (0%)	0	1/68 (1.5%)	1	0/108 (0%)	0
Injury, poisoning and procedural complications
Animal bite	0/156 (0%)	0	0/101 (0%)	0	1/107 (0.9%)	1	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Arthropod bite	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Arthropod sting	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Concussion	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Exposure during pregnancy	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Facial bones fracture	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Fall	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	1/112 (0.9%)	1	1/518 (0.2%)	1	1/776 (0.1%)	1	2/513 (0.4%)	2	1/141 (0.7%)	1	0/213 (0%)	0
Infusion related reaction	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	2/518 (0.4%)	2	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Joint injury	0/156 (0%)	0	1/101 (1%)	1	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Ligament rupture	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Ligament sprain	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Limb injury	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Lower limb fracture	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Maternal exposure during pregnancy	0/85 (0%)	0	0/63 (0%)	0	1/51 (2%)	1	0/58 (0%)	0	0/58 (0%)	0	0/279 (0%)	0	0/404 (0%)	0	0/265 (0%)	0	0/68 (0%)	0	0/108 (0%)	0
Nail avulsion	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Procedural pain	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Rib fracture	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Road traffic accident	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Skin abrasion	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Skin laceration	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	1/112 (0.9%)	1	1/518 (0.2%)	1	0/776 (0%)	0	1/513 (0.2%)	1	1/141 (0.7%)	1	1/213 (0.5%)	1
Tibia fracture	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Upper limb fracture	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Vaccination complication	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Investigations
Alanine aminotransferase increased	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	1/101 (1%)	1	0/112 (0%)	0	1/518 (0.2%)	1	2/776 (0.3%)	2	1/513 (0.2%)	1	1/141 (0.7%)	1	0/213 (0%)	0
Amylase increased	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	1/112 (0.9%)	1	0/518 (0%)	0	2/776 (0.3%)	2	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Aspartate aminotransferase increased	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	1/776 (0.1%)	1	0/513 (0%)	0	1/141 (0.7%)	1	0/213 (0%)	0
Blood alkaline phosphatase increased	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Blood bicarbonate decreased	0/156 (0%)	0	0/101 (0%)	0	1/107 (0.9%)	1	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Blood creatine phosphokinase increased	0/156 (0%)	0	0/101 (0%)	0	1/107 (0.9%)	1	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	1/776 (0.1%)	1	0/513 (0%)	0	1/141 (0.7%)	1	0/213 (0%)	0
Blood creatinine increased	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Blood glucose increased	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Blood lactate dehydrogenase increased	0/156 (0%)	0	1/101 (1%)	1	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Blood phosphorus decreased	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Blood pressure increased	0/156 (0%)	0	2/101 (2%)	4	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Blood urea increased	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Blood uric acid increased	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	1/101 (1%)	1	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Blood urine	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
C-reactive protein increased	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	1/101 (1%)	1	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	2/513 (0.4%)	2	1/141 (0.7%)	1	0/213 (0%)	0
Electrocardiogram t wave abnormal	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	1/101 (1%)	1	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Eosinophil count increased	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	1/112 (0.9%)	1	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Epstein-barr virus antibody positive	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Fibrin d dimer increased	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	1/213 (0.5%)	1
Heart rate irregular	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Hepatic enzyme increased	0/156 (0%)	0	1/101 (1%)	1	0/107 (0%)	0	0/101 (0%)	0	1/112 (0.9%)	1	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Lipase increased	0/156 (0%)	0	1/101 (1%)	1	0/107 (0%)	0	2/101 (2%)	2	0/112 (0%)	0	1/518 (0.2%)	1	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Liver function test increased	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	3/776 (0.4%)	3	3/513 (0.6%)	3	0/141 (0%)	0	0/213 (0%)	0
Lymphocyte morphology abnormal	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	1/112 (0.9%)	1	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Neutrophil count decreased	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	1/141 (0.7%)	1	0/213 (0%)	0
Neutrophil count increased	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Occult blood positive	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Platelet count decreased	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Platelet count increased	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Serum ferritin increased	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Transaminases increased	0/156 (0%)	0	1/101 (1%)	1	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Weight decreased	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
White blood cell count decreased	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	1/112 (0.9%)	1	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	1/141 (0.7%)	1	0/213 (0%)	0
Metabolism and nutrition disorders
Acidosis	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Dehydration	2/156 (1.3%)	2	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Diabetes mellitus	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	1/141 (0.7%)	1	0/213 (0%)	0
Diabetic ketoacidosis	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Glucose tolerance impaired	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Gout	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	2/776 (0.3%)	2	2/513 (0.4%)	2	0/141 (0%)	0	1/213 (0.5%)	1
Hypercholesterolaemia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	1/141 (0.7%)	1	0/213 (0%)	0
Hyperglycaemia	0/156 (0%)	0	0/101 (0%)	0	1/107 (0.9%)	1	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	2/513 (0.4%)	2	0/141 (0%)	0	0/213 (0%)	0
Hyperkalaemia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Hyperlipidaemia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	2/518 (0.4%)	2	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Hypoglycaemia	0/156 (0%)	0	0/101 (0%)	0	1/107 (0.9%)	1	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Hypokalaemia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	1/213 (0.5%)	1
Hypophosphataemia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	1/101 (1%)	1	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Hypovolaemia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Iron deficiency	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Malnutrition	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Type 2 diabetes mellitus	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	2/518 (0.4%)	2	1/776 (0.1%)	1	2/513 (0.4%)	2	1/141 (0.7%)	1	0/213 (0%)	0
Vitamin b12 deficiency	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	1/213 (0.5%)	1
Vitamin d deficiency	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	2/776 (0.3%)	2	2/513 (0.4%)	2	1/141 (0.7%)	1	1/213 (0.5%)	1
Back pain	1/156 (0.6%)	1	1/101 (1%)	1	0/107 (0%)	0	0/101 (0%)	0	1/112 (0.9%)	1	1/518 (0.2%)	1	2/776 (0.3%)	2	4/513 (0.8%)	4	0/141 (0%)	0	1/213 (0.5%)	1
Coccydynia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	1/112 (0.9%)	1	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Extremity contracture	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Fibromyalgia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	1/213 (0.5%)	1
Flank pain	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	1/101 (1%)	1	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Joint contracture	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Joint swelling	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Muscle spasms	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	1/101 (1%)	1	0/112 (0%)	0	0/518 (0%)	0	2/776 (0.3%)	2	2/513 (0.4%)	2	0/141 (0%)	0	0/213 (0%)	0
Muscle twitching	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	1/101 (1%)	1	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Muscular weakness	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	1/112 (0.9%)	1	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Musculoskeletal chest pain	0/156 (0%)	0	0/101 (0%)	0	1/107 (0.9%)	1	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Musculoskeletal stiffness	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	1/112 (0.9%)	1	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Myalgia	0/156 (0%)	0	1/101 (1%)	2	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Neck pain	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	1/101 (1%)	1	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Osteoarthritis	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Pain in extremity	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	1/776 (0.1%)	1	0/513 (0%)	0	1/141 (0.7%)	1	0/213 (0%)	0
Pain in jaw	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Periarthritis	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Rheumatoid arthritis	0/156 (0%)	0	0/101 (0%)	0	1/107 (0.9%)	1	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Rotator cuff syndrome	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Spinal pain	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	1/101 (1%)	1	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Nervous system disorders
Balance disorder	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	1/101 (1%)	1	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Burning sensation	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Dizziness	3/156 (1.9%)	3	3/101 (3%)	3	3/107 (2.8%)	3	3/101 (3%)	4	1/112 (0.9%)	1	4/518 (0.8%)	4	3/776 (0.4%)	4	4/513 (0.8%)	5	0/141 (0%)	0	0/213 (0%)	0
Dysgeusia	2/156 (1.3%)	2	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	2/518 (0.4%)	2	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Headache	2/156 (1.3%)	2	3/101 (3%)	3	2/107 (1.9%)	2	0/101 (0%)	0	1/112 (0.9%)	1	1/518 (0.2%)	1	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Hypoaesthesia	2/156 (1.3%)	2	1/101 (1%)	1	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	1/141 (0.7%)	1	0/213 (0%)	0
Hyporeflexia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Incoherent	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Loss of consciousness	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Mental impairment	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Migraine	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	1/101 (1%)	1	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Nerve compression	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	1/213 (0.5%)	1
Paraesthesia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	1/112 (0.9%)	2	1/518 (0.2%)	1	2/776 (0.3%)	2	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Parkinson's disease	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Presyncope	0/156 (0%)	0	1/101 (1%)	1	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Restless legs syndrome	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Sciatica	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	2/513 (0.4%)	2	0/141 (0%)	0	0/213 (0%)	0
Somnolence	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	1/101 (1%)	1	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Syncope	2/156 (1.3%)	2	0/101 (0%)	0	1/107 (0.9%)	1	1/101 (1%)	1	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Tremor	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Pregnancy, puerperium and perinatal conditions
Pregnancy	0/85 (0%)	0	0/63 (0%)	0	1/51 (2%)	1	0/58 (0%)	0	0/58 (0%)	0	0/279 (0%)	0	0/404 (0%)	0	0/265 (0%)	0	0/68 (0%)	0	0/108 (0%)	0
Psychiatric disorders
Anxiety	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	3/776 (0.4%)	3	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Bipolar disorder	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Depression	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	1/141 (0.7%)	1	0/213 (0%)	0
Hallucination, auditory	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Insomnia	0/156 (0%)	0	0/101 (0%)	0	1/107 (0.9%)	1	1/101 (1%)	2	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Irritability	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Panic attack	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	1/776 (0.1%)	1	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Restlessness	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	1/112 (0.9%)	1	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Renal and urinary disorders
Chromaturia	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Dysuria	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Haematuria	0/156 (0%)	0	0/101 (0%)	0	1/107 (0.9%)	1	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Nephrolithiasis	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	2/776 (0.3%)	2	3/513 (0.6%)	3	0/141 (0%)	0	0/213 (0%)	0
Pollakiuria	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Renal cyst	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	1/213 (0.5%)	1
Renal pain	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Urinary incontinence	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	1/101 (1%)	1	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Reproductive system and breast disorders
Benign prostatic hyperplasia	0/71 (0%)	0	0/38 (0%)	0	0/56 (0%)	0	0/43 (0%)	0	0/54 (0%)	0	0/239 (0%)	0	0/372 (0%)	0	0/248 (0%)	0	1/73 (1.4%)	1	0/105 (0%)	0
Menstruation delayed	0/85 (0%)	0	0/63 (0%)	0	0/51 (0%)	0	0/58 (0%)	0	0/58 (0%)	0	0/279 (0%)	0	1/404 (0.2%)	1	0/265 (0%)	0	0/68 (0%)	0	0/108 (0%)	0
Menstruation irregular	0/85 (0%)	0	0/63 (0%)	0	0/51 (0%)	0	0/58 (0%)	0	0/58 (0%)	0	1/279 (0.4%)	1	0/404 (0%)	0	0/265 (0%)	0	0/68 (0%)	0	0/108 (0%)	0
Vulva cyst	0/85 (0%)	0	0/63 (0%)	0	0/51 (0%)	0	0/58 (0%)	0	0/58 (0%)	0	0/279 (0%)	0	0/404 (0%)	0	0/265 (0%)	0	0/68 (0%)	0	1/108 (0.9%)	1
Respiratory, thoracic and mediastinal disorders
Asthma	1/156 (0.6%)	1	1/101 (1%)	1	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Atelectasis	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	1/112 (0.9%)	1	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Cough	1/156 (0.6%)	1	1/101 (1%)	1	0/107 (0%)	0	0/101 (0%)	0	1/112 (0.9%)	1	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Dyspnoea	0/156 (0%)	0	1/101 (1%)	1	1/107 (0.9%)	1	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Epistaxis	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Nasal congestion	1/156 (0.6%)	1	2/101 (2%)	2	1/107 (0.9%)	1	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Oropharyngeal discomfort	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Oropharyngeal pain	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	2/112 (1.8%)	2	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	1/141 (0.7%)	1	0/213 (0%)	0
Paranasal sinus discomfort	0/156 (0%)	0	1/101 (1%)	1	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Pharyngeal swelling	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Pleurisy	0/156 (0%)	0	1/101 (1%)	1	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Pulmonary embolism	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Respiratory failure	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Rhinalgia	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	3/513 (0.6%)	3	0/141 (0%)	0	0/213 (0%)	0
Rhinitis allergic	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Rhinorrhoea	0/156 (0%)	0	1/101 (1%)	1	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Sinus congestion	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	1/112 (0.9%)	1	1/518 (0.2%)	1	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Throat irritation	0/156 (0%)	0	1/101 (1%)	1	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Upper-airway cough syndrome	0/156 (0%)	0	0/101 (0%)	0	1/107 (0.9%)	1	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Skin and subcutaneous tissue disorders
Alopecia	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	2/101 (2%)	2	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Cold sweat	0/156 (0%)	0	0/101 (0%)	0	1/107 (0.9%)	1	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Dermatitis contact	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	1/213 (0.5%)	1
Dry skin	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Erythema	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Hyperhidrosis	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Ingrowing nail	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Night sweats	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	1/112 (0.9%)	1	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Pruritus	1/156 (0.6%)	1	2/101 (2%)	2	3/107 (2.8%)	3	0/101 (0%)	0	2/112 (1.8%)	2	3/518 (0.6%)	3	0/776 (0%)	0	3/513 (0.6%)	3	0/141 (0%)	0	0/213 (0%)	0
Rash	1/156 (0.6%)	1	1/101 (1%)	1	0/107 (0%)	0	1/101 (1%)	1	1/112 (0.9%)	1	6/518 (1.2%)	6	6/776 (0.8%)	6	3/513 (0.6%)	3	2/141 (1.4%)	2	0/213 (0%)	0
Rash pruritic	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Rosacea	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Skin disorder	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Urticaria	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	1/101 (1%)	1	0/112 (0%)	0	2/518 (0.4%)	2	1/776 (0.1%)	1	1/513 (0.2%)	1	1/141 (0.7%)	1	0/213 (0%)	0
Social circumstances
Bereavement	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	1/112 (0.9%)	1	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Surgical and medical procedures
Abortion induced	0/85 (0%)	0	0/63 (0%)	0	1/51 (2%)	1	0/58 (0%)	0	0/58 (0%)	0	0/279 (0%)	0	0/404 (0%)	0	0/265 (0%)	0	0/68 (0%)	0	0/108 (0%)	0
Appendicectomy	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Thrombectomy	1/156 (0.6%)	1	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Vascular disorders
Arteriosclerosis	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	1/776 (0.1%)	1	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Deep vein thrombosis	0/156 (0%)	0	1/101 (1%)	1	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Dialysis hypotension	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	1/518 (0.2%)	1	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Flushing	1/156 (0.6%)	1	0/101 (0%)	0	1/107 (0.9%)	1	0/101 (0%)	0	1/112 (0.9%)	1	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Haematoma	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Hot flush	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	1/213 (0.5%)	1
Hypertension	1/156 (0.6%)	1	1/101 (1%)	1	0/107 (0%)	0	3/101 (3%)	3	0/112 (0%)	0	2/518 (0.4%)	2	2/776 (0.3%)	2	1/513 (0.2%)	1	2/141 (1.4%)	2	1/213 (0.5%)	1
Hypotension	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	2/518 (0.4%)	2	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Orthostatic hypotension	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	1/112 (0.9%)	1	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0
Peripheral artery occlusion	0/156 (0%)	0	0/101 (0%)	0	0/107 (0%)	0	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	1/513 (0.2%)	1	0/141 (0%)	0	0/213 (0%)	0
Phlebitis	0/156 (0%)	0	0/101 (0%)	0	1/107 (0.9%)	1	0/101 (0%)	0	0/112 (0%)	0	0/518 (0%)	0	0/776 (0%)	0	0/513 (0%)	0	0/141 (0%)	0	0/213 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.