BLAZE-2: A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Preventing SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04497987
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID) (NIH), AbCellera Biologics Inc. (Industry), Shanghai Junshi Bioscience Co., Ltd. (Other)
• Enrollment: 1,180
• Locations: 27
• Arms: 9
• Actual Duration (Months): 9.6
• Patients Per Site: 43.7
• Patients Per Site Per Month: 4.6

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate whether LY3819253 given alone and with LY3832479 prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease - 2019 (COVID-19). Facility staff and residents in contracted skilled nursing and assisted living facility networks with a high risk of SARS-CoV-2 exposure will receive LY3819253, LY3819253 and LY3832479, or placebo via an injection into a vein. Samples will be taken from the nose. Blood samples will be drawn. Participation could last up to 25 weeks and may include up to 19 visits.

Condition or Disease	Intervention/Treatment	Phase
COVID-19; SARS-CoV2	Drug: Bamlanivimab; Drug: Placebo; Drug: Etesevimab	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of LY3819253 Alone and in Combination With LY3832479 in Preventing SARS-CoV-2 Infection and COVID-19 in Skilled Nursing and Assisted Living Facility Residents and Staff; a NIAID and Lilly Collaborative Study
• Actual Study Start Date: Aug 2, 2020
• Actual Primary Completion Date: Jan 16, 2021
• Actual Study Completion Date: May 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bamlanivimab (Part 1) Participants received single Intravenous (IV) infusion of 4200 milligrams (mg) bamlanivimab.	Drug: Bamlanivimab; Administered IV.; Other Names: LY-CoV555 LY3819253
Placebo Comparator: Placebo (Part 1) Participants received single IV infusion of Placebo.	Drug: Placebo; Administered IV.
Experimental: Bamlanivimab (Part 2-Prevention) Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.	Drug: Bamlanivimab; Administered IV.; Other Names: LY-CoV555 LY3819253
Experimental: Bamlanivimab + Etesevimab (Part 2-Prevention) Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.	Drug: Bamlanivimab; Administered IV.; Other Names: LY-CoV555 LY3819253 ; Drug: Etesevimab; Administered IV.; Other Names: LY-CoV016 LY3832479
Placebo Comparator: Placebo Comparator: Placebo (Part 2-Prevention) Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.	Drug: Placebo; Administered IV.
Experimental: Bamlanivimab (Part 2 - Treatment) Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.	Drug: Bamlanivimab; Administered IV.; Other Names: LY-CoV555 LY3819253
Experimental: Bamlanivimab + Etesevimab (Part 2- Treatment) Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.	Drug: Bamlanivimab; Administered IV.; Other Names: LY-CoV555 LY3819253 ; Drug: Etesevimab; Administered IV.; Other Names: LY-CoV016 LY3832479
Experimental: Bamlanivimab (Part 3) Part 3 of the study is exploratory, conducted to study exploratory objectives and is not reported in this record. [Participants received single IV infusion of 700 mg bamlanivimab.]	Drug: Bamlanivimab; Administered IV.; Other Names: LY-CoV555 LY3819253
Experimental: Bamlanivimab + Etesevimab (Part 3) Part 3 of the study is exploratory, conducted to study exploratory objectives and is not reported in this record. [Participants received single IV infusion of 700 mg bamlanivimab given with 1400 mg etesevimab.]	Drug: Bamlanivimab; Administered IV.; Other Names: LY-CoV555 LY3819253 ; Drug: Etesevimab; Administered IV.; Other Names: LY-CoV016 LY3832479

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With COVID-19 [Week 8 after randomization]

   The endpoint for the primary analysis is defined as the first occurrence of coronavirus disease - 2019 (COVID-19), defined as the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by reverse transcription - polymerase chain reaction (RT-PCR) AND mild or worse disease severity within 21 days of detection, by Day 57 (8 weeks after randomization). The participant needed to test positive on or prior to week 8, and they needed to develop their symptoms on or after their positive test date, but no later than 21 days after their positive swab OR Week 8, whichever comes first. Logistic regression model was used which includes occurrence of a primary endpoint event as the response variable, and treatment and stratification factors such as facility as explanatory variables.

Secondary Outcome Measures

1. Percentage of Participants With Moderate or Worse Severity COVID-19 [Week 8 after randomization]

   The endpoint defined as the detection of SARS-CoV-2 by polymerase chain reaction (RT-PCR) AND moderate or worse disease severity within 21 days of detection, by Day 57 (Week 8) were summarized by treatment group. The participant needed to test positive on or prior to week 8, and they needed to develop their symptoms on or after their positive test date, but no later than 21 days after their positive swab OR Week 8, whichever comes first. Logistic regression model was used which includes occurrence of a primary endpoint event as the response variable, and treatment and stratification factors such as facility as explanatory variables.

2. Percentage of Participants With SARS-CoV-2 [Week 4]

   Percentage of Participants with SARS-CoV-2.

3. Percentage of Participants Who Are Hospitalized or Have Died Due to COVID-19 [Week 8]

   Percentage of Participants Who are Hospitalized or Have Died due to COVID-19.

4. Percentage of Participants Who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death [Week 8]

   Percentage of Participants who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death.

5. Percentage of Participants Who Die Due to COVID-19 [Week 8]

   Percentage of Participants Who Die Due to COVID-19.

6. Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone [Day 29, 57, 85, 141 and 169]

   Pharmacokinetics (PK): Mean Concentration of bamlanivimab Administered Alone.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Part 1 and Part 2: Resident or facility staff in a skilled nursing or assisted living facility with at least one confirmed case of SARS-CoV-2 detection less than or equal to (≤)7 days prior to randomization

• Are men or non-pregnant women who agree to contraceptive requirements

• Agree to the collection of nasal, mid-turbinate, oropharyngeal, and nasopharyngeal swabs, and venous blood as specified in the schedule of activities

• Have venous access sufficient to allow intravenous infusions and blood sampling

• The participant or legally authorized representative give signed informed consent

• Part 3 only: Resident or staff in a skilled nursing or assisted living facility who satisfy at least one of the following at the time of screening

• Are greater than or equal to (≥) 65 years of age

• Have a body mass index (BMI) ≥ 35

• Have chronic kidney disease

• 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, OR

• hypertension, OR

• chronic obstructive pulmonary disease or other chronic respiratory disease

• Positive SARS-CoV-2 test and infusion within 10 days of symptom onset, OR positive SARS-CoV-2 test and infusion within 10 days of testing if asymptomatic

Exclusion Criteria:

• Parts 1 and 2:

• Recovered from confirmed COVID-19 disease or asymptomatic infection

• Prior history of a positive SARS-CoV-2 serology test

• History of convalescent COVID-19 plasma treatment

• Participation in a previous SARS-CoV-2 vaccine trial or received an approved SARS-CoV-2 vaccine

• Previous receipt of SAR-CoV-2-specific monoclonal antibodies

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Unv of AL Sch of Med Div of Infectious Diseases	Birmingham	Alabama	United States	35294
2	Care Access Research	Phoenix	Arizona	United States	85023
3	Allergy and Asthma Clin of NW Ark	Bentonville	Arkansas	United States	72712
4	Care Access Research LLC	Huntington Beach	California	United States	92648
5	Alta Bates SMC	Oakland	California	United States	94609
6	University of Colorado-Anschultz Medical Campus	Aurora	Colorado	United States	80045
7	NIAID	Miami	Florida	United States	33136
8	NIAID	Decatur	Georgia	United States	30030
9	Belmont Village Lincoln Park	Lincoln Park	Illinois	United States	60614
10	Family Medicine	Indianapolis	Indiana	United States	46260
11	University of Louisville	Louisville	Kentucky	United States	40202
12	Care Access Rch Lake Charles	Lake Charles	Louisiana	United States	70601
13	Tulane University School of Medicine	New Orleans	Louisiana	United States	70112 2715
14	NIAID - National Institute of Allergy & Infectious Diseases	Bethesda	Maryland	United States	20892
15	Care Access	Boston	Massachusetts	United States	02110
16	St. Paul IDA-CARe	Saint Paul	Minnesota	United States	55101
17	Care Access	Jackson	Mississippi	United States	39206
18	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
19	Children's Hospital & Medical Center	Omaha	Nebraska	United States	68114
20	Care Access Research - Bronx	Bronx	New York	United States	10456
21	NIAD	Chapel Hill	North Carolina	United States	27599
22	Valley Medical Primary Care	Centerville	Ohio	United States	45459
23	Univ of Cin College of Med	Cincinnati	Ohio	United States	45219
24	OSU Med Intl Med Houston Ctr	Tulsa	Oklahoma	United States	74127
25	Donahoe Manor	Bedford	Pennsylvania	United States	15522
26	Belmont Village, West Univ	Houston	Texas	United States	77025
27	Burke Internal Medicine and Research	Burke	Virginia	United States	22015

Sponsors and Collaborators

• Eli Lilly and Company
• National Institute of Allergy and Infectious Diseases (NIAID)
• 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 - Jan 22, 2021
• Statistical Analysis Plan - Dec 7, 2020

More Information

Additional Information:

• A Study of LY3819253 (LY-CoV555) to Prevent SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff (BLAZE-2)

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT04497987
• Other Study ID Numbers: 18063; J2X-MC-PYAD; CoVPN #3501
• First Posted: Aug 4, 2020
• Last Update Posted: Feb 4, 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
• Keywords provided by Eli Lilly and Company: Prevention
• Additional relevant MeSH terms: COVID-19; Bamlanivimab

Study Results

Participant Flow

Recruitment Details

This trial was planned as a 3-part study. Part 1 was to evaluate the efficacy and safety of bamlanivimab (BAM) in preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease 2019 (COVID-19), compared with Placebo (PBO). Part 2 was to demonstrate superior efficacy of BAM and BAM + ETE over PBO in the prevention of COVID-19. Part 3 was exploratory cohort.

Pre-assignment Detail

Enrollment for Part 2 was not initiated because the efficacy of BAM 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.

Arm/Group Title	Placebo	4200 mg Bamlanivimab
Arm/Group Description	Participants received single IV infusion of Placebo.	Participants received single IV infusion of 4200 milligrams (mg) bamlanivimab.
Period Title: Overall Study
STARTED	592	588
Received at Least One Dose of Study Drug	587	588
Prevention Population	485	487
Treatment Population	68	66
Serology Positive	36	35
COMPLETED	493	521
NOT COMPLETED	99	67

Baseline Characteristics

Arm/Group Title	Placebo	4200 mg Bamlanivimab	Total
Arm/Group Description	Participants received single IV infusion of Placebo.	Participants received single IV infusion of 4200 mg bamlanivimab.	Total of all reporting groups
Overall Participants	587	588	1175
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.2 (20.3)	53.4 (20.7)	52.8 (20.5)
Sex: Female, Male (Count of Participants)
Female	443 75.5%	434 73.8%	877 74.6%
Male	144 24.5%	154 26.2%	298 25.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	36 6.1%	26 4.4%	62 5.3%
Not Hispanic or Latino	551 93.9%	561 95.4%	1112 94.6%
Unknown or Not Reported	0 0%	1 0.2%	1 0.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.2%	4 0.7%	5 0.4%
Asian	8 1.4%	6 1%	14 1.2%
Native Hawaiian or Other Pacific Islander	3 0.5%	2 0.3%	5 0.4%
Black or African American	52 8.9%	48 8.2%	100 8.5%
White	515 87.7%	519 88.3%	1034 88%
More than one race	3 0.5%	5 0.9%	8 0.7%
Unknown or Not Reported	5 0.9%	4 0.7%	9 0.8%
Region of Enrollment (Count of Participants)
United States	587 100%	588 100%	1175 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With COVID-19
Description	The endpoint for the primary analysis is defined as the first occurrence of coronavirus disease - 2019 (COVID-19), defined as the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by reverse transcription - polymerase chain reaction (RT-PCR) AND mild or worse disease severity within 21 days of detection, by Day 57 (8 weeks after randomization). The participant needed to test positive on or prior to week 8, and they needed to develop their symptoms on or after their positive test date, but no later than 21 days after their positive swab OR Week 8, whichever comes first. Logistic regression model was used which includes occurrence of a primary endpoint event as the response variable, and treatment and stratification factors such as facility as explanatory variables.
Time Frame	Week 8 after randomization

Outcome Measure Data

Analysis Population Description

All randomized participants from prevention population.

Arm/Group Title	Placebo	4200mg Bamlanivimab
Arm/Group Description	Participants received single IV infusion of Placebo.	Participants received single IV infusion of 4200mg bamlanivimab.
Measure Participants	485	487
Number (95% Confidence Interval) [Percentage of Participants]	15.7 2.7%	8.3 1.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, 4200mg Bamlanivimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.40
	Confidence Interval	(2-Sided) 95%; 0.26 to 0.63
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Percentage of Participants With Moderate or Worse Severity COVID-19
Description	The endpoint defined as the detection of SARS-CoV-2 by polymerase chain reaction (RT-PCR) AND moderate or worse disease severity within 21 days of detection, by Day 57 (Week 8) were summarized by treatment group. The participant needed to test positive on or prior to week 8, and they needed to develop their symptoms on or after their positive test date, but no later than 21 days after their positive swab OR Week 8, whichever comes first. Logistic regression model was used which includes occurrence of a primary endpoint event as the response variable, and treatment and stratification factors such as facility as explanatory variables.
Time Frame	Week 8 after randomization

Outcome Measure Data

Analysis Population Description

All randomized participants from prevention population.

Arm/Group Title	Placebo	4200mg Bamlanivimab
Arm/Group Description	Participants received single IV infusion of Placebo.	Participants received single IV infusion of 4200mg bamlanivimab.
Measure Participants	485	487
Number (95% Confidence Interval) [Percentage of Participants]	14.7 2.5%	8.1 1.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, 4200mg Bamlanivimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.43
	Confidence Interval	(2-Sided) 95%; 0.27 to 0.67
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Percentage of Participants With SARS-CoV-2
Description	Percentage of Participants with SARS-CoV-2.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

All randomized participants from prevention population.

Arm/Group Title	Placebo	4200mg Bamlanivimab
Arm/Group Description	Participants received single IV infusion of Placebo.	Participants received single IV infusion of 4200mg bamlanivimab.
Measure Participants	485	487
Number (95% Confidence Interval) [Percentage of Participants]	23.1 3.9%	17.8 3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, 4200mg Bamlanivimab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.021
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.66
	Confidence Interval	(2-Sided) 95%; 0.46 to 0.94
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Percentage of Participants Who Are Hospitalized or Have Died Due to COVID-19
Description	Percentage of Participants Who are Hospitalized or Have Died due to COVID-19.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

All randomized participants from prevention population.

Arm/Group Title	Placebo	4200mg Bamlanivimab
Arm/Group Description	Participants received single IV infusion of Placebo.	Participants received single IV infusion of 4200mg bamlanivimab.
Measure Participants	485	487
Number (95% Confidence Interval) [Percentage of Participants]	1.4 0.2%	0.4 0.1%

5. Secondary Outcome

Title	Percentage of Participants Who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death
Description	Percentage of Participants who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

All randomized participants from prevention population.

Arm/Group Title	Placebo	4200mg Bamlanivimab
Arm/Group Description	Participants received single IV infusion of Placebo.	Participants received single IV infusion of 4200mg bamlanivimab.
Measure Participants	485	487
Number (95% Confidence Interval) [Percentage of Participants]	1.4 0.2%	0.6 0.1%

6. Secondary Outcome

Title	Percentage of Participants Who Die Due to COVID-19
Description	Percentage of Participants Who Die Due to COVID-19.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

All randomized participants from prevention population.

Arm/Group Title	Placebo	4200mg Bamlanivimab
Arm/Group Description	Participants received single IV infusion of Placebo.	Participants received single IV infusion of 4200mg bamlanivimab.
Measure Participants	485	487
Number (95% Confidence Interval) [Percentage of Participants]	0.8 0.1%	0 0%

7. Secondary Outcome

Title	Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone
Description	Pharmacokinetics (PK): Mean Concentration of bamlanivimab Administered Alone.
Time Frame	Day 29, 57, 85, 141 and 169

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of bamlanivimab and had evaluable PK data.

Arm/Group Title	4200mg Bamlanivimab
Arm/Group Description	Participants received single IV infusion of 4200mg bamlanivimab.
Measure Participants	557
Day 29	162 (44.4)
Day 57	61.8 (59.9)
Day 85	28.4 (61.6)
Day 141	17.5 (46.2)
Day 169	15.1 (42.3)

Adverse Events

Time Frame	Baseline, up to 9 Months
Adverse Event Reporting Description	All randomized 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	Placebo		4200mg Bamlanivimab
Arm/Group Description	Participants received single IV infusion of Placebo.		Participants received single IV infusion of 4200mg bamlanivimab.
All Cause Mortality
	Placebo		4200mg Bamlanivimab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/587 (3.6%)		13/588 (2.2%)
Serious Adverse Events
	Placebo		4200mg Bamlanivimab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	30/587 (5.1%)		39/588 (6.6%)
Blood and lymphatic system disorders
Anaemia	0/587 (0%)	0	1/588 (0.2%)	1
Iron deficiency anaemia	0/587 (0%)	0	1/588 (0.2%)	1
Thrombocytopenia	0/587 (0%)	0	1/588 (0.2%)	1
Cardiac disorders
Acute myocardial infarction	0/587 (0%)	0	2/588 (0.3%)	2
Atrial fibrillation	0/587 (0%)	0	3/588 (0.5%)	3
Cardiac failure	0/587 (0%)	0	1/588 (0.2%)	1
Cardiac failure acute	0/587 (0%)	0	0/588 (0%)	0
Cardiac failure congestive	2/587 (0.3%)	3	2/588 (0.3%)	2
Cardio-respiratory arrest	1/587 (0.2%)	1	1/588 (0.2%)	1
Cardiomyopathy	0/587 (0%)	0	0/588 (0%)	0
Coronary artery disease	1/587 (0.2%)	1	1/588 (0.2%)	1
Myocardial infarction	1/587 (0.2%)	1	1/588 (0.2%)	1
Endocrine disorders
Thyrotoxic crisis	1/587 (0.2%)	1	0/588 (0%)	0
Gastrointestinal disorders
Abdominal distension	1/587 (0.2%)	1	0/588 (0%)	0
Abdominal pain upper	0/587 (0%)	0	0/588 (0%)	0
Ascites	1/587 (0.2%)	1	0/588 (0%)	0
Gastrointestinal haemorrhage	0/587 (0%)	0	1/588 (0.2%)	1
Mouth haemorrhage	1/587 (0.2%)	1	0/588 (0%)	0
Oesophageal ulcer	1/587 (0.2%)	1	0/588 (0%)	0
Small intestinal obstruction	0/587 (0%)	0	1/588 (0.2%)	1
General disorders
Death	1/587 (0.2%)	1	1/588 (0.2%)	1
Gait disturbance	0/587 (0%)	0	1/588 (0.2%)	1
Sudden death	0/587 (0%)	0	0/588 (0%)	0
Hepatobiliary disorders
Bile duct stone	0/587 (0%)	0	1/588 (0.2%)	1
Hepatic cirrhosis	0/587 (0%)	0	0/588 (0%)	0
Infections and infestations
Acquired immunodeficiency syndrome	0/587 (0%)	0	1/588 (0.2%)	1
Bacteraemia	1/587 (0.2%)	1	0/588 (0%)	0
Clostridium difficile infection	0/587 (0%)	0	0/588 (0%)	0
Escherichia bacteraemia	0/587 (0%)	0	1/588 (0.2%)	1
Escherichia urinary tract infection	1/587 (0.2%)	1	0/588 (0%)	0
Gastroenteritis	0/587 (0%)	0	1/588 (0.2%)	1
Groin abscess	0/587 (0%)	0	1/588 (0.2%)	1
Osteomyelitis	1/587 (0.2%)	1	0/588 (0%)	0
Pneumonia	2/587 (0.3%)	2	2/588 (0.3%)	2
Pyelonephritis	1/587 (0.2%)	1	0/588 (0%)	0
Sepsis	3/587 (0.5%)	3	3/588 (0.5%)	3
Septic shock	1/587 (0.2%)	1	2/588 (0.3%)	2
Upper respiratory tract infection	1/587 (0.2%)	1	0/588 (0%)	0
Urinary tract infection	0/587 (0%)	0	5/588 (0.9%)	6
Injury, poisoning and procedural complications
Fall	2/587 (0.3%)	2	0/588 (0%)	0
Femur fracture	1/587 (0.2%)	1	0/588 (0%)	0
Hip fracture	1/587 (0.2%)	1	0/588 (0%)	0
Injury corneal	1/587 (0.2%)	1	0/588 (0%)	0
Limb injury	0/587 (0%)	0	0/588 (0%)	0
Multiple injuries	0/587 (0%)	0	1/588 (0.2%)	1
Open globe injury	1/587 (0.2%)	1	0/588 (0%)	0
Road traffic accident	0/587 (0%)	0	1/588 (0.2%)	1
Spinal compression fracture	0/587 (0%)	0	1/588 (0.2%)	1
Investigations
Blood creatinine increased	1/587 (0.2%)	1	0/588 (0%)	0
Metabolism and nutrition disorders
Hyperkalaemia	1/587 (0.2%)	1	0/588 (0%)	0
Hypoglycaemia	0/587 (0%)	0	1/588 (0.2%)	1
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis	0/587 (0%)	0	1/588 (0.2%)	1
Nervous system disorders
Cerebrovascular accident	1/587 (0.2%)	1	1/588 (0.2%)	1
Dementia	1/587 (0.2%)	1	0/588 (0%)	0
Headache	0/587 (0%)	0	1/588 (0.2%)	1
Hypoaesthesia	0/587 (0%)	0	1/588 (0.2%)	1
Metabolic encephalopathy	0/587 (0%)	0	0/588 (0%)	0
Paraesthesia	0/587 (0%)	0	2/588 (0.3%)	2
Syncope	1/587 (0.2%)	1	0/588 (0%)	0
Transient ischaemic attack	0/587 (0%)	0	2/588 (0.3%)	2
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	1/443 (0.2%)	1	0/434 (0%)	0
Psychiatric disorders
Depression suicidal	0/587 (0%)	0	1/588 (0.2%)	1
Mental status changes	0/587 (0%)	0	1/588 (0.2%)	2
Post-traumatic stress disorder	0/587 (0%)	0	1/588 (0.2%)	1
Renal and urinary disorders
Acute kidney injury	1/587 (0.2%)	1	1/588 (0.2%)	1
End stage renal disease	1/587 (0.2%)	1	1/588 (0.2%)	1
Nephrolithiasis	1/587 (0.2%)	1	0/588 (0%)	0
Renal artery stenosis	1/587 (0.2%)	1	0/588 (0%)	0
Ureterolithiasis	1/587 (0.2%)	1	0/588 (0%)	0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	0/587 (0%)	0	2/588 (0.3%)	2
Chronic obstructive pulmonary disease	0/587 (0%)	0	2/588 (0.3%)	2
Epistaxis	1/587 (0.2%)	1	0/588 (0%)	0
Hypoxia	0/587 (0%)	0	1/588 (0.2%)	1
Pneumonia aspiration	0/587 (0%)	0	1/588 (0.2%)	1
Pulmonary mass	1/587 (0.2%)	1	0/588 (0%)	0
Respiratory failure	0/587 (0%)	0	1/588 (0.2%)	1
Skin and subcutaneous tissue disorders
Hyperhidrosis	0/587 (0%)	0	0/588 (0%)	0
Ingrowing nail	0/587 (0%)	0	0/588 (0%)	0
Vascular disorders
Hypovolaemic shock	1/587 (0.2%)	1	0/588 (0%)	0
Lymphoedema	0/587 (0%)	0	1/588 (0.2%)	1
Other (Not Including Serious) Adverse Events
	Placebo		4200mg Bamlanivimab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	147/587 (25%)		145/588 (24.7%)
Blood and lymphatic system disorders
Anaemia	2/587 (0.3%)	2	1/588 (0.2%)	1
Leukocytosis	1/587 (0.2%)	1	0/588 (0%)	0
Thrombocytopenia	2/587 (0.3%)	2	0/588 (0%)	0
Cardiac disorders
Angina pectoris	0/587 (0%)	0	1/588 (0.2%)	1
Atrial thrombosis	0/587 (0%)	0	1/588 (0.2%)	1
Cardiac failure congestive	1/587 (0.2%)	1	1/588 (0.2%)	1
Cardiomegaly	1/587 (0.2%)	1	0/588 (0%)	0
Palpitations	0/587 (0%)	0	3/588 (0.5%)	3
Sinus bradycardia	1/587 (0.2%)	1	0/588 (0%)	0
Tachycardia	0/587 (0%)	0	1/588 (0.2%)	1
Ventricular fibrillation	0/587 (0%)	0	1/588 (0.2%)	1
Ear and labyrinth disorders
Ear pain	0/587 (0%)	0	2/588 (0.3%)	3
Eustachian tube dysfunction	0/587 (0%)	0	1/588 (0.2%)	1
Excessive cerumen production	1/587 (0.2%)	1	0/588 (0%)	0
Tinnitus	1/587 (0.2%)	1	1/588 (0.2%)	1
Vertigo	1/587 (0.2%)	1	5/588 (0.9%)	5
Endocrine disorders
Adrenal insufficiency	0/587 (0%)	0	0/588 (0%)	0
Hyperparathyroidism	1/587 (0.2%)	1	0/588 (0%)	0
Eye disorders
Eye discharge	0/587 (0%)	0	1/588 (0.2%)	1
Eye pruritus	1/587 (0.2%)	1	0/588 (0%)	0
Retinal detachment	1/587 (0.2%)	1	0/588 (0%)	0
Gastrointestinal disorders
Abdominal discomfort	1/587 (0.2%)	1	1/588 (0.2%)	1
Abdominal hernia	1/587 (0.2%)	1	0/588 (0%)	0
Abdominal pain	2/587 (0.3%)	2	2/588 (0.3%)	2
Abdominal pain upper	0/587 (0%)	0	1/588 (0.2%)	1
Anal incontinence	0/587 (0%)	0	0/588 (0%)	0
Aphthous ulcer	1/587 (0.2%)	1	0/588 (0%)	0
Constipation	3/587 (0.5%)	3	3/588 (0.5%)	3
Dental caries	1/587 (0.2%)	1	0/588 (0%)	0
Diarrhoea	0/587 (0%)	0	1/588 (0.2%)	2
Dyspepsia	2/587 (0.3%)	2	2/588 (0.3%)	3
Faecaloma	1/587 (0.2%)	1	0/588 (0%)	0
Gastric disorder	0/587 (0%)	0	1/588 (0.2%)	1
Gastrooesophageal reflux disease	1/587 (0.2%)	1	3/588 (0.5%)	3
Glossodynia	0/587 (0%)	0	1/588 (0.2%)	1
Large intestine polyp	0/587 (0%)	0	1/588 (0.2%)	1
Mouth ulceration	0/587 (0%)	0	1/588 (0.2%)	1
Nausea	1/587 (0.2%)	1	1/588 (0.2%)	1
Oesophagitis	1/587 (0.2%)	1	0/588 (0%)	0
Oral pain	1/587 (0.2%)	1	0/588 (0%)	0
Stomatitis	0/587 (0%)	0	1/588 (0.2%)	1
Toothache	0/587 (0%)	0	1/588 (0.2%)	1
Upper gastrointestinal haemorrhage	0/587 (0%)	0	0/588 (0%)	0
Vomiting	0/587 (0%)	0	1/588 (0.2%)	1
General disorders
Asthenia	1/587 (0.2%)	1	0/588 (0%)	0
Chest pain	0/587 (0%)	0	1/588 (0.2%)	1
Face oedema	1/587 (0.2%)	1	0/588 (0%)	0
Feeling hot	0/587 (0%)	0	0/588 (0%)	0
Infusion site haemorrhage	0/587 (0%)	0	1/588 (0.2%)	1
Injection site extravasation	0/587 (0%)	0	1/588 (0.2%)	1
Non-cardiac chest pain	1/587 (0.2%)	1	1/588 (0.2%)	1
Oedema	1/587 (0.2%)	1	1/588 (0.2%)	1
Oedema peripheral	0/587 (0%)	0	1/588 (0.2%)	1
Puncture site haematoma	1/587 (0.2%)	1	0/588 (0%)	0
Pyrexia	0/587 (0%)	0	1/588 (0.2%)	1
Swelling face	0/587 (0%)	0	1/588 (0.2%)	1
Hepatobiliary disorders
Hepatic cirrhosis	1/587 (0.2%)	1	0/588 (0%)	0
Hepatic function abnormal	1/587 (0.2%)	1	0/588 (0%)	0
Immune system disorders
Food allergy	0/587 (0%)	0	1/588 (0.2%)	1
Hypersensitivity	0/587 (0%)	0	1/588 (0.2%)	1
Serum sickness	1/587 (0.2%)	1	0/588 (0%)	0
Infections and infestations
Abscess	0/587 (0%)	0	0/588 (0%)	0
Bronchitis	3/587 (0.5%)	3	1/588 (0.2%)	1
Candida infection	2/587 (0.3%)	2	0/588 (0%)	0
Cellulitis	1/587 (0.2%)	1	1/588 (0.2%)	1
Clostridium difficile infection	0/587 (0%)	0	2/588 (0.3%)	2
Conjunctivitis	1/587 (0.2%)	1	0/588 (0%)	0
Cystitis	1/587 (0.2%)	1	0/588 (0%)	0
Device related infection	1/587 (0.2%)	1	0/588 (0%)	0
Diverticulitis	1/587 (0.2%)	1	0/588 (0%)	0
Ear infection	2/587 (0.3%)	2	2/588 (0.3%)	2
Endocarditis	0/587 (0%)	0	1/588 (0.2%)	1
Eye infection	1/587 (0.2%)	1	0/588 (0%)	0
Fungal infection	1/587 (0.2%)	1	0/588 (0%)	0
Gastrointestinal bacterial infection	0/587 (0%)	0	1/588 (0.2%)	1
Kidney infection	1/587 (0.2%)	1	0/588 (0%)	0
Labyrinthitis	0/587 (0%)	0	1/588 (0.2%)	1
Localised infection	0/587 (0%)	0	1/588 (0.2%)	1
Nasopharyngitis	1/587 (0.2%)	1	2/588 (0.3%)	2
Oral candidiasis	0/587 (0%)	0	1/588 (0.2%)	1
Oral herpes	0/587 (0%)	0	0/588 (0%)	0
Osteomyelitis	0/587 (0%)	0	1/588 (0.2%)	1
Pharyngitis streptococcal	2/587 (0.3%)	2	0/588 (0%)	0
Pilonidal cyst	1/587 (0.2%)	1	0/588 (0%)	0
Pneumonia	7/587 (1.2%)	7	2/588 (0.3%)	2
Rhinitis	1/587 (0.2%)	1	1/588 (0.2%)	1
Sinusitis	8/587 (1.4%)	8	2/588 (0.3%)	2
Subcutaneous abscess	0/587 (0%)	0	1/588 (0.2%)	1
Tooth abscess	1/587 (0.2%)	1	3/588 (0.5%)	3
Tooth infection	0/587 (0%)	0	3/588 (0.5%)	4
Urinary tract infection	20/587 (3.4%)	22	11/588 (1.9%)	13
Vaginal infection	0/443 (0%)	0	1/434 (0.2%)	1
Viral infection	0/587 (0%)	0	1/588 (0.2%)	1
Injury, poisoning and procedural complications
Animal bite	1/587 (0.2%)	1	0/588 (0%)	0
Animal scratch	1/587 (0.2%)	1	0/588 (0%)	0
Concussion	0/587 (0%)	0	1/588 (0.2%)	1
Contusion	2/587 (0.3%)	2	3/588 (0.5%)	3
Fall	9/587 (1.5%)	12	6/588 (1%)	6
Foot fracture	1/587 (0.2%)	1	0/588 (0%)	0
Head injury	1/587 (0.2%)	1	0/588 (0%)	0
Humerus fracture	1/587 (0.2%)	1	0/588 (0%)	0
Joint dislocation	1/587 (0.2%)	1	0/588 (0%)	0
Joint injury	1/587 (0.2%)	1	0/588 (0%)	0
Ligament sprain	1/587 (0.2%)	1	0/588 (0%)	0
Limb injury	2/587 (0.3%)	2	0/588 (0%)	0
Lower limb fracture	1/587 (0.2%)	1	0/588 (0%)	0
Lumbar vertebral fracture	0/587 (0%)	0	1/588 (0.2%)	1
Muscle strain	1/587 (0.2%)	1	0/588 (0%)	0
Rib fracture	0/587 (0%)	0	1/588 (0.2%)	1
Skin laceration	1/587 (0.2%)	1	2/588 (0.3%)	3
Soft tissue injury	1/587 (0.2%)	1	0/588 (0%)	0
Spinal compression fracture	0/587 (0%)	0	1/588 (0.2%)	1
Tibia fracture	2/587 (0.3%)	2	0/588 (0%)	0
Tooth fracture	1/587 (0.2%)	1	0/588 (0%)	0
Vaccination complication	1/587 (0.2%)	1	0/588 (0%)	0
Wrist fracture	0/587 (0%)	0	1/588 (0.2%)	1
Investigations
Alanine aminotransferase increased	0/587 (0%)	0	1/588 (0.2%)	1
Amylase increased	1/587 (0.2%)	1	0/588 (0%)	0
Aspartate aminotransferase increased	0/587 (0%)	0	1/588 (0.2%)	1
Blood albumin decreased	0/587 (0%)	0	2/588 (0.3%)	2
Blood alkaline phosphatase increased	1/587 (0.2%)	1	0/588 (0%)	0
Blood bilirubin increased	1/587 (0.2%)	1	1/588 (0.2%)	1
Blood creatinine increased	1/587 (0.2%)	1	0/588 (0%)	0
Blood glucose increased	2/587 (0.3%)	2	1/588 (0.2%)	1
Blood potassium decreased	0/587 (0%)	0	1/588 (0.2%)	2
Blood pressure increased	1/587 (0.2%)	1	3/588 (0.5%)	3
Blood sodium decreased	1/587 (0.2%)	1	0/588 (0%)	0
Blood urea increased	1/587 (0.2%)	1	1/588 (0.2%)	1
Brain natriuretic peptide increased	0/587 (0%)	0	1/588 (0.2%)	1
Breath sounds abnormal	0/587 (0%)	0	0/588 (0%)	0
C-reactive protein increased	1/587 (0.2%)	1	0/588 (0%)	0
Capillary nail refill test abnormal	0/587 (0%)	0	0/588 (0%)	0
Gamma-glutamyltransferase increased	2/587 (0.3%)	2	1/588 (0.2%)	1
Haemoglobin increased	1/587 (0.2%)	1	0/588 (0%)	0
Hepatic enzyme increased	0/587 (0%)	0	1/588 (0.2%)	1
International normalised ratio increased	0/587 (0%)	0	0/588 (0%)	0
Neutrophil count decreased	0/587 (0%)	0	1/588 (0.2%)	1
Neutrophil count increased	1/587 (0.2%)	1	0/588 (0%)	0
Procalcitonin increased	0/587 (0%)	0	0/588 (0%)	0
Smear cervix abnormal	0/443 (0%)	0	1/434 (0.2%)	1
Troponin increased	0/587 (0%)	0	1/588 (0.2%)	1
White blood cell count decreased	0/587 (0%)	0	1/588 (0.2%)	1
White blood cell count increased	1/587 (0.2%)	1	0/588 (0%)	0
Metabolism and nutrition disorders
Dehydration	3/587 (0.5%)	4	1/588 (0.2%)	1
Dyslipidaemia	1/587 (0.2%)	1	0/588 (0%)	0
Glucose tolerance impaired	1/587 (0.2%)	1	0/588 (0%)	0
Gout	0/587 (0%)	0	1/588 (0.2%)	1
Hypercalcaemia	1/587 (0.2%)	1	0/588 (0%)	0
Hyperkalaemia	2/587 (0.3%)	2	0/588 (0%)	0
Hyperlipidaemia	1/587 (0.2%)	1	0/588 (0%)	0
Hyperproteinaemia	1/587 (0.2%)	1	0/588 (0%)	0
Hypoalbuminaemia	0/587 (0%)	0	0/588 (0%)	0
Hypokalaemia	2/587 (0.3%)	2	1/588 (0.2%)	1
Metabolic acidosis	1/587 (0.2%)	1	0/588 (0%)	0
Vitamin b complex deficiency	0/587 (0%)	0	1/588 (0.2%)	1
Vitamin d deficiency	0/587 (0%)	0	2/588 (0.3%)	2
Musculoskeletal and connective tissue disorders
Arthralgia	4/587 (0.7%)	4	7/588 (1.2%)	8
Back pain	6/587 (1%)	6	5/588 (0.9%)	5
Bursitis	0/587 (0%)	0	1/588 (0.2%)	1
Coccydynia	0/587 (0%)	0	1/588 (0.2%)	1
Flank pain	1/587 (0.2%)	1	0/588 (0%)	0
Inguinal mass	1/587 (0.2%)	1	0/588 (0%)	0
Intervertebral disc degeneration	1/587 (0.2%)	1	0/588 (0%)	0
Intervertebral disc protrusion	1/587 (0.2%)	1	0/588 (0%)	0
Joint effusion	0/587 (0%)	0	1/588 (0.2%)	1
Joint range of motion decreased	0/587 (0%)	0	1/588 (0.2%)	1
Joint swelling	0/587 (0%)	0	1/588 (0.2%)	1
Muscle spasms	1/587 (0.2%)	1	1/588 (0.2%)	1
Neck pain	2/587 (0.3%)	2	2/588 (0.3%)	2
Osteonecrosis	0/587 (0%)	0	1/588 (0.2%)	1
Pain in extremity	3/587 (0.5%)	3	4/588 (0.7%)	4
Sjogren's syndrome	1/587 (0.2%)	1	0/588 (0%)	0
Spinal stenosis	0/587 (0%)	0	1/588 (0.2%)	1
Trochlear dysplasia	1/587 (0.2%)	1	0/588 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma	1/443 (0.2%)	1	0/434 (0%)	0
Plasma cell myeloma	1/587 (0.2%)	1	0/588 (0%)	0
Prostate cancer	1/144 (0.7%)	1	0/154 (0%)	0
Seborrhoeic keratosis	0/587 (0%)	0	0/588 (0%)	0
Nervous system disorders
Bell's palsy	0/587 (0%)	0	1/588 (0.2%)	1
Carpal tunnel syndrome	1/587 (0.2%)	1	0/588 (0%)	0
Cubital tunnel syndrome	1/587 (0.2%)	1	0/588 (0%)	0
Dizziness	6/587 (1%)	6	5/588 (0.9%)	6
Dizziness postural	1/587 (0.2%)	1	0/588 (0%)	0
Dysgeusia	0/587 (0%)	0	1/588 (0.2%)	1
Headache	2/587 (0.3%)	2	2/588 (0.3%)	2
Hypoaesthesia	0/587 (0%)	0	2/588 (0.3%)	2
Metabolic encephalopathy	1/587 (0.2%)	1	0/588 (0%)	0
Migraine	1/587 (0.2%)	1	0/588 (0%)	0
Paraesthesia	1/587 (0.2%)	1	0/588 (0%)	0
Sciatica	0/587 (0%)	0	1/588 (0.2%)	1
Syncope	3/587 (0.5%)	3	1/588 (0.2%)	1
Tremor	0/587 (0%)	0	1/588 (0.2%)	1
Psychiatric disorders
Anorgasmia	0/587 (0%)	0	1/588 (0.2%)	1
Anxiety	0/587 (0%)	0	2/588 (0.3%)	2
Anxiety disorder	1/587 (0.2%)	1	0/588 (0%)	0
Confusional state	0/587 (0%)	0	1/588 (0.2%)	1
Delusion	1/587 (0.2%)	1	0/588 (0%)	0
Depression	1/587 (0.2%)	1	3/588 (0.5%)	3
Generalised anxiety disorder	0/587 (0%)	0	0/588 (0%)	0
Insomnia	2/587 (0.3%)	2	1/588 (0.2%)	1
Mental status changes	1/587 (0.2%)	1	0/588 (0%)	0
Renal and urinary disorders
Acute kidney injury	0/587 (0%)	0	1/588 (0.2%)	1
Bladder spasm	1/587 (0.2%)	1	0/588 (0%)	0
Dysuria	0/587 (0%)	0	1/588 (0.2%)	1
Haematuria	2/587 (0.3%)	2	0/588 (0%)	0
Nephrolithiasis	3/587 (0.5%)	3	0/588 (0%)	0
Renal failure	1/587 (0.2%)	1	0/588 (0%)	0
Renal impairment	1/587 (0.2%)	1	0/588 (0%)	0
Urinary tract obstruction	1/587 (0.2%)	1	0/588 (0%)	0
Reproductive system and breast disorders
Breast mass	1/587 (0.2%)	1	0/588 (0%)	0
Dysmenorrhoea	0/443 (0%)	0	1/434 (0.2%)	1
Ovarian cyst ruptured	1/443 (0.2%)	1	0/434 (0%)	0
Vulvovaginal pruritus	0/443 (0%)	0	1/434 (0.2%)	1
Respiratory, thoracic and mediastinal disorders
Asthma	1/587 (0.2%)	1	0/588 (0%)	0
Chronic obstructive pulmonary disease	1/587 (0.2%)	1	1/588 (0.2%)	1
Dysphonia	1/587 (0.2%)	1	1/588 (0.2%)	1
Dyspnoea	0/587 (0%)	0	1/588 (0.2%)	1
Epistaxis	2/587 (0.3%)	2	2/588 (0.3%)	2
Haemoptysis	0/587 (0%)	0	1/588 (0.2%)	1
Hypoxia	0/587 (0%)	0	1/588 (0.2%)	1
Nasal congestion	5/587 (0.9%)	5	1/588 (0.2%)	1
Oropharyngeal pain	1/587 (0.2%)	1	0/588 (0%)	0
Paranasal sinus discomfort	0/587 (0%)	0	1/588 (0.2%)	1
Pharyngeal paraesthesia	1/587 (0.2%)	1	0/588 (0%)	0
Pulmonary fibrosis	0/587 (0%)	0	0/588 (0%)	0
Sinus congestion	0/587 (0%)	0	1/588 (0.2%)	1
Sinus pain	1/587 (0.2%)	1	0/588 (0%)	0
Sleep apnoea syndrome	0/587 (0%)	0	0/588 (0%)	0
Sneezing	1/587 (0.2%)	1	0/588 (0%)	0
Wheezing	1/587 (0.2%)	1	0/588 (0%)	0
Skin and subcutaneous tissue disorders
Decubitus ulcer	0/587 (0%)	0	0/588 (0%)	0
Dermatitis allergic	1/587 (0.2%)	1	0/588 (0%)	0
Dermatitis contact	0/587 (0%)	0	1/588 (0.2%)	1
Diabetic foot	1/587 (0.2%)	1	0/588 (0%)	0
Ecchymosis	0/587 (0%)	0	2/588 (0.3%)	2
Eczema	1/587 (0.2%)	1	0/588 (0%)	0
Erythema	1/587 (0.2%)	1	2/588 (0.3%)	2
Hyperhidrosis	1/587 (0.2%)	1	1/588 (0.2%)	1
Night sweats	0/587 (0%)	0	1/588 (0.2%)	1
Pruritus	1/587 (0.2%)	1	2/588 (0.3%)	2
Rash	1/587 (0.2%)	1	5/588 (0.9%)	5
Skin exfoliation	1/587 (0.2%)	1	0/588 (0%)	0
Skin ulcer	0/587 (0%)	0	1/588 (0.2%)	1
Skin wrinkling	0/587 (0%)	0	0/588 (0%)	0
Stasis dermatitis	0/587 (0%)	0	0/588 (0%)	0
Urticaria	1/587 (0.2%)	1	4/588 (0.7%)	4
Surgical and medical procedures
Dental operation	1/587 (0.2%)	1	0/588 (0%)	0
Knee arthroplasty	1/587 (0.2%)	1	0/588 (0%)	0
Retinopexy	0/587 (0%)	0	1/588 (0.2%)	1
Salpingo-oophorectomy unilateral	1/443 (0.2%)	1	0/434 (0%)	0
Sinus operation	0/587 (0%)	0	1/588 (0.2%)	1
Spinal laminectomy	0/587 (0%)	0	1/588 (0.2%)	1
Tooth extraction	0/587 (0%)	0	1/588 (0.2%)	1
Vascular disorders
Aortic arteriosclerosis	1/587 (0.2%)	1	0/588 (0%)	0
Deep vein thrombosis	0/587 (0%)	0	1/588 (0.2%)	1
Flushing	2/587 (0.3%)	2	2/588 (0.3%)	2
Haematoma	1/587 (0.2%)	1	1/588 (0.2%)	1
Hypertension	11/587 (1.9%)	11	8/588 (1.4%)	8
Hypotension	1/587 (0.2%)	1	0/588 (0%)	0
Lymphoedema	0/587 (0%)	0	1/588 (0.2%)	1

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.