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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04427501
Recruitment Status : Recruiting
First Posted : June 11, 2020
Results First Posted : March 7, 2022
Last Update Posted : September 9, 2022
Sponsor:
Collaborators:
AbCellera Biologics Inc.
Shanghai Junshi Bioscience Co., Ltd.
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition COVID-19
Interventions Drug: LY3819253
Drug: LY3832479
Drug: LY3853113
Drug: Placebo
Enrollment 3360
Recruitment Details  
Pre-assignment Details

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
Hide 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 [1] 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
Reason Not Completed
Death             0             0             0             0             0             15             0             0             0             0
Lost to Follow-up             5             1             2             0             2             11             10             10             2             5
Physician Decision             0             3             0             0             0             0             2             0             0             0
Withdrawal by Subject             9             2             2             3             7             25             15             7             4             1
Other - as reported by the investigator             1             0             0             0             0             6             6             0             0             0
[1]
Participants in Placebo for Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab and Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab were 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 Total
Hide 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 Number of Baseline Participants 156 101 107 101 112 776 518 513 141 213 2738
Hide Baseline Analysis Population Description
All randomized participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 156 participants 101 participants 107 participants 101 participants 112 participants 776 participants 518 participants 513 participants 141 participants 213 participants 2738 participants
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 156 participants 101 participants 107 participants 101 participants 112 participants 776 participants 518 participants 513 participants 141 participants 213 participants 2738 participants
Female 85 63 51 58 58 404 279 265 68 108 1439
Male 71 38 56 43 54 372 239 248 73 105 1299
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 156 participants 101 participants 107 participants 101 participants 112 participants 776 participants 518 participants 513 participants 141 participants 213 participants 2738 participants
Hispanic or Latino 69 49 47 39 42 226 149 139 36 53 849
Not Hispanic or Latino 87 52 60 62 70 548 368 373 104 160 1884
Unknown or Not Reported 0 0 0 0 0 2 1 1 1 0 5
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 156 participants 101 participants 107 participants 101 participants 112 participants 776 participants 518 participants 513 participants 141 participants 213 participants 2738 participants
American Indian or Alaska Native 2 1 0 0 0 2 2 3 2 3 15
Asian 8 1 5 3 2 33 16 18 6 6 98
Native Hawaiian or Other Pacific Islander 0 0 1 0 0 4 0 1 0 0 6
Black or African American 7 7 7 8 4 61 44 41 16 28 223
White 133 90 90 89 105 667 449 445 116 175 2359
More than one race 1 2 1 0 0 2 1 2 0 0 9
Unknown or Not Reported 5 0 3 1 1 7 6 3 1 1 28
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 156 participants 101 participants 107 participants 101 participants 112 participants 776 participants 518 participants 513 participants 141 participants 213 participants 2738 participants
156 101 107 101 112 776 518 513 141 213 2738
SARS-CoV-2 Viral Load   [1] 
Mean (Standard Deviation)
Unit of measure:  Cycle threshold (Ct)
Number Analyzed 152 participants 101 participants 107 participants 101 participants 109 participants 774 participants 508 participants 510 participants 141 participants 213 participants 2716 participants
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)
[1]
Measure Analysis Population Description: All participants who received at least one dose of study drug and had at least 1 post-baseline viral load measurement. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to a lower viral load.
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 517 518 776 511
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
7.0
(4.8 to 9.2)
2.1
(0.9 to 3.4)
6.8
(5.1 to 8.6)
0.8
(0.0 to 1.5)
Hide 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 [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
0.15 to 0.58
Estimation Comments [Not Specified]
Hide 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 [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
0.04 to 0.31
Estimation Comments [Not Specified]
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants received Placebo administered intravenously (IV).
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
Overall Number of Participants Analyzed 141 213
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
34.8
(26.9 to 42.6)
10.8
(6.6 to 15.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab, Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.23
Confidence Interval (2-Sided) 95%
0.13 to 0.40
Estimation Comments [Not Specified]
3.Primary Outcome
Title Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 146 100 103 95 102
Least Squares Mean (Standard Error)
Unit of Measure: unitless
-3.80  (0.141) -3.72  (0.170) -4.08  (0.168) -3.49  (0.175) -4.37  (0.169)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part A: Placebo, Phase 2: 700 mg Bamlanivimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6921
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
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 [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part A: Placebo, Phase 2: 2800 mg Bamlanivimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2110
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
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 [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part A: Placebo, Phase 2: 7000 mg Bamlanivimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1630
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
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 [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Part A: Placebo, Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0099
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
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 [Not Specified]
4.Primary Outcome
Title Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 156 101 107 101 112
Measure Type: Number
Unit of Measure: percentage of participants
0.6 0 0 0 0.9
5.Secondary Outcome
Title Phase 3: Percentage of Participants Demonstrating Symptom Resolution
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 499 508 774 510 141 213
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
52.1
(47.7 to 56.5)
61.2
(57.0 to 65.5)
50.9
(47.4 to 54.4)
61.8
(57.5 to 66.0)
51.8
(43.5 to 60.0)
63.8
(57.4 to 70.3)
Hide 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 [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.45
Confidence Interval (2-Sided) 95%
1.13 to 1.86
Estimation Comments [Not Specified]
Hide 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 [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.56
Confidence Interval (2-Sided) 95%
1.24 to 1.95
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab, Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.64
Confidence Interval (2-Sided) 95%
1.06 to 2.53
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Phase 3: Percentage of Participants Demonstrating Symptom Improvement
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 499 508 774 510 141 213
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
40.9
(36.6 to 45.2)
51.0
(46.6 to 55.3)
40.1
(36.6 to 43.5)
52.7
(48.4 to 57.1)
38.3
(30.3 to 46.3)
54.0
(47.3 to 60.7)
Hide 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 [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.50
Confidence Interval (2-Sided) 95%
1.17 to 1.93
Estimation Comments [Not Specified]
Hide 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 [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.67
Confidence Interval (2-Sided) 95%
1.33 to 2.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab, Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.88
Confidence Interval (2-Sided) 95%
1.22 to 2.9
Estimation Comments [Not Specified]
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 517 518 716 511 141 231
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
7.2
(4.9 to 9.4)
2.5
(1.2 to 3.9)
7.0
(5.2 to 8.7)
1.2
(0.2 to 2.1)
4.3
(0.9 to 7.6)
0.9
(0.0 to 2.2)
Hide 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 [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
0.18 to 0.64
Estimation Comments [Not Specified]
Hide 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 [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.17
Confidence Interval (2-Sided) 95%
0.07 to 0.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab, Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.25
Confidence Interval (2-Sided) 95%
0.06 to 1.05
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Phase 3: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 403 455 614 399 122 194
Least Squares Mean (Standard Error)
Unit of Measure: 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)
Hide 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 [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0000000
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.20
Confidence Interval (2-Sided) 95%
-1.46 to -0.94
Estimation Comments [Not Specified]
Hide 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 [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0000000
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.09
Confidence Interval (2-Sided) 95%
-1.34 to -0.85
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab, Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00003777
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.99
Confidence Interval (2-Sided) 95%
-1.45 to -0.52
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Phase 3: Time to Sustained Symptom Resolution
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 499 508 774 510 141 213
Median (95% Confidence Interval)
Unit of Measure: Days
9.00
(8.00 to 10.00)
8.00
(7.00 to 8.00)
9.00
(9.00 to 10.00)
8.00
(7.00 to 9.00)
9.00
(8.00 to 13.00)
6.00
(5.00 to 8.00)
Hide 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 [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Stratified Log-rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.213
Estimation Comments [Not Specified]
Hide 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 [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.130
Comments [Not Specified]
Method Stratified Log-rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.111
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab, Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Stratified Log-rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.380
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Phase 3: Time to SARS-CoV-2 Viral Clearance
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 499 508 774 510 141 213
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(14.00 to NA)
[1]
Median cannot be calculated due to insufficient number of events occurring within the timeframe.
Hide 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 [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Stratified Log-rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.355
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab, Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.033
Comments [Not Specified]
Method Stratified Log-rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.237
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab, Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method Stratified Log-rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.521
Estimation Comments [Not Specified]
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 123 84 88 81 95
Least Squares Mean (Standard Error)
Unit of Measure: unitless
-4.03  (0.155) -3.87  (0.187) -4.20  (0.184) -3.65  (0.191) -4.46  (0.178)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase 2: Placebo, Phase 2: 700 mg Bamlanivimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.499
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
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 [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Phase 2: Placebo, Phase 2: 2800 mg Bamlanivimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.492
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
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 [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Phase 2: Placebo, Phase 2: 7000 mg Bamlanivimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.125
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
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 [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Phase 2: Placebo, Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.069
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
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 [Not Specified]
12.Secondary Outcome
Title Phase 2: Percentage of Participants Demonstrating Symptom Resolution
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 152 101 107 101 109
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
36.8
(29.2 to 44.5)
50.5
(40.7 to 60.2)
40.2
(30.9 to 49.5)
43.6
(33.9 to 53.2)
45.9
(36.5 to 55.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase 2: Placebo, Phase 2: 700 mg Bamlanivimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.74
Confidence Interval (2-Sided) 95%
1.04 to 2.90
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Phase 2: Placebo, Phase 2: 2800 mg Bamlanivimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.594
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.15
Confidence Interval (2-Sided) 95%
0.69 to 1.91
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Phase 2: Placebo, Phase 2: 7000 mg Bamlanivimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.291
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
0.79 to 2.20
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Phase 2: Placebo, Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.143
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.45
Confidence Interval (2-Sided) 95%
0.88 to 2.40
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Phase 2: Percentage of Participants Demonstrating Symptom Improvement
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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..
Overall Number of Participants Analyzed 152 101 107 101 109
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
43.4
(35.5 to 51.3)
59.4
(49.8 to 69.0)
44.9
(35.4 to 54.3)
58.4
(48.8 to 68.0)
53.2
(43.8 to 62.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase 2: Placebo, Phase 2: 700 mg Bamlanivimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.89
Confidence Interval (2-Sided) 95%
1.14 to 3.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Phase 2: Placebo, Phase 2: 2800 mg Bamlanivimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.828
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.64 to 1.74
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Phase 2: Placebo, Phase 2: 7000 mg Bamlanivimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.82
Confidence Interval (2-Sided) 95%
1.09 to 3.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Phase 2: Placebo, Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.119
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.48
Confidence Interval (2-Sided) 95%
0.90 to 2.43
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Phase 2, Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Alone and in the Presence of Etesevimab
Hide Description (PK): Mean Concentration of Bamlanivimab alone and in the Presence of Etesevimab
Time Frame Day 29 Post-dose
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 80 89 86 92
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: 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
Hide Description PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab
Time Frame Day 29 Post-dose
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
Overall Number of Participants Analyzed 92
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: 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
Hide Description Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related ER Visit, or Death from Any Cause
Time Frame Baseline through Day 85
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 156 101 107 101 112
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5.8
(2.1 to 9.4)
1.0
(0.0 to 2.9)
1.9
(0.0 to 4.4)
2.0
(0.0 to 4.7)
0.9
(0.0 to 2.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part A: Placebo, Phase 2: 700 mg Bamlanivimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.098
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.23
Confidence Interval (2-Sided) 95%
0.04 to 1.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part A: Placebo, Phase 2: 2800 mg Bamlanivimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.165
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
0.09 to 1.51
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part A: Placebo, Phase 2: 7000 mg Bamlanivimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.191
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
0.10 to 1.60
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Part A: Placebo, Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.075
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.21
Confidence Interval (2-Sided) 95%
0.04 to 1.18
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Phase 2: Time to SARS-CoV-2 Viral Clearance
Hide 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
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Hide 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
Hide 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..
Overall Number of Participants Analyzed 152 101 107 101 109
Median (95% Confidence Interval)
Unit of Measure: Days
24 [1] 
(22.00 to NA)
25.00
(21.00 to 27.00)
23.00
(19.00 to 25.00)
25.00 [1] 
(22.00 to NA)
21.00 [1] 
(17.00 to NA)
[1]
Some upper bound confidence intervals were not estimable due to insufficient events occurring within the timeframe.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase 2: Placebo, Phase 2: 700 mg Bamlanivimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.616
Comments [Not Specified]
Method Stratified Log-rank
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Phase 2: Placebo, Phase 2: 2800 mg Bamlanivimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.281
Comments [Not Specified]
Method Stratified Log-rank
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Phase 2: Placebo, Phase 2: 7000 mg Bamlanivimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.815
Comments [Not Specified]
Method Stratified Log-rank
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Phase 2: Placebo, Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.334
Comments [Not Specified]
Method Stratified Log-rank
Comments [Not Specified]
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/156 (0.00%)      0/101 (0.00%)      0/107 (0.00%)      0/101 (0.00%)      0/112 (0.00%)      0/518 (0.00%)      15/776 (1.93%)      0/513 (0.00%)      0/141 (0.00%)      0/213 (0.00%)    
Hide 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 (0.64%)      2/101 (1.98%)      0/107 (0.00%)      0/101 (0.00%)      1/112 (0.89%)      10/518 (1.93%)      8/776 (1.03%)      16/513 (3.12%)      4/141 (2.84%)      1/213 (0.47%)    
Cardiac disorders                     
Acute myocardial infarction  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 1/518 (0.19%)  1 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Angina pectoris  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 1/513 (0.19%)  2 0/141 (0.00%)  0 0/213 (0.00%)  0
Angina unstable  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 1/513 (0.19%)  1 0/141 (0.00%)  0 0/213 (0.00%)  0
Atrial fibrillation  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 1/518 (0.19%)  1 0/776 (0.00%)  0 1/513 (0.19%)  1 0/141 (0.00%)  0 0/213 (0.00%)  0
Atrial flutter  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 1/518 (0.19%)  1 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Cardiac arrest  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 0/513 (0.00%)  0 1/141 (0.71%)  1 0/213 (0.00%)  0
Coronary artery disease  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 1/513 (0.19%)  1 0/141 (0.00%)  0 0/213 (0.00%)  0
Myocardial infarction  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 0/513 (0.00%)  0 1/141 (0.71%)  1 0/213 (0.00%)  0
Ventricular extrasystoles  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 1/518 (0.19%)  1 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Eye disorders                     
Macular oedema  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 1/513 (0.19%)  1 0/141 (0.00%)  0 0/213 (0.00%)  0
Retinal vein occlusion  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 1/513 (0.19%)  1 0/141 (0.00%)  0 0/213 (0.00%)  0
Gastrointestinal disorders                     
Abdominal pain  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 1/776 (0.13%)  1 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Colitis  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 1/776 (0.13%)  1 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Duodenitis  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 1/513 (0.19%)  1 0/141 (0.00%)  0 0/213 (0.00%)  0
Gastritis  1  1/156 (0.64%)  1 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Gastrointestinal haemorrhage  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 1/513 (0.19%)  1 0/141 (0.00%)  0 0/213 (0.00%)  0
Gastrooesophageal reflux disease  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 1/513 (0.19%)  1 0/141 (0.00%)  0 0/213 (0.00%)  0
Intestinal obstruction  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 1/513 (0.19%)  1 0/141 (0.00%)  0 0/213 (0.00%)  0
Intussusception  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 1/513 (0.19%)  1 0/141 (0.00%)  0 0/213 (0.00%)  0
Small intestinal obstruction  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 1/776 (0.13%)  1 1/513 (0.19%)  1 0/141 (0.00%)  0 0/213 (0.00%)  0
General disorders                     
Chest pain  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 0/513 (0.00%)  0 1/141 (0.71%)  1 0/213 (0.00%)  0
Sudden death  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 1/776 (0.13%)  1 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Hepatobiliary disorders                     
Cholecystitis acute  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 1/513 (0.19%)  1 0/141 (0.00%)  0 0/213 (0.00%)  0
Infections and infestations                     
Covid-19 pneumonia  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 0/513 (0.00%)  0 1/141 (0.71%)  1 0/213 (0.00%)  0
Localised infection  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 1/513 (0.19%)  1 0/141 (0.00%)  0 0/213 (0.00%)  0
Medical device site joint infection  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 1/513 (0.19%)  1 0/141 (0.00%)  0 0/213 (0.00%)  0
Perirectal abscess  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 1/776 (0.13%)  1 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Sialoadenitis  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 1/513 (0.19%)  1 0/141 (0.00%)  0 0/213 (0.00%)  0
Urinary tract infection  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 1/112 (0.89%)  1 0/518 (0.00%)  0 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Injury, poisoning and procedural complications                     
Bone contusion  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 0/513 (0.00%)  0 1/141 (0.71%)  1 0/213 (0.00%)  0
Concussion  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 0/513 (0.00%)  0 1/141 (0.71%)  1 0/213 (0.00%)  0
Femur fracture  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 1/213 (0.47%)  1
Foot fracture  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 1/513 (0.19%)  1 0/141 (0.00%)  0 0/213 (0.00%)  0
Hip fracture  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 0/513 (0.00%)  0 1/141 (0.71%)  1 0/213 (0.00%)  0
Injury  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 1/518 (0.19%)  1 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Road traffic accident  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 1/518 (0.19%)  1 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Toxicity to various agents  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 1/518 (0.19%)  1 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Investigations                     
Catheterisation cardiac  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 1/518 (0.19%)  1 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Metabolism and nutrition disorders                     
Dehydration  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 1/776 (0.13%)  1 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Diabetic ketoacidosis  1  0/156 (0.00%)  0 1/101 (0.99%)  1 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 1/518 (0.19%)  1 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Hyperglycaemia  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 1/518 (0.19%)  1 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Hyponatraemia  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 1/518 (0.19%)  1 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                     
Clear cell renal cell carcinoma  1  0/156 (0.00%)  0 1/101 (0.99%)  1 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Lung neoplasm malignant  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 1/513 (0.19%)  1 0/141 (0.00%)  0 0/213 (0.00%)  0
Nervous system disorders                     
Syncope  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 1/776 (0.13%)  1 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Renal and urinary disorders                     
Acute kidney injury  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 1/518 (0.19%)  1 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Reproductive system and breast disorders                     
Heavy menstrual bleeding  1  0/85 (0.00%)  0 0/63 (0.00%)  0 0/51 (0.00%)  0 0/58 (0.00%)  0 0/58 (0.00%)  0 1/279 (0.36%)  1 0/404 (0.00%)  0 0/265 (0.00%)  0 0/68 (0.00%)  0 0/108 (0.00%)  0
Uterine mass  1  0/85 (0.00%)  0 0/63 (0.00%)  0 0/51 (0.00%)  0 0/58 (0.00%)  0 0/58 (0.00%)  0 0/279 (0.00%)  0 1/404 (0.25%)  1 0/265 (0.00%)  0 0/68 (0.00%)  0 0/108 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                     
Asthma  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 1/518 (0.19%)  1 0/776 (0.00%)  0 1/513 (0.19%)  1 0/141 (0.00%)  0 0/213 (0.00%)  0
Epistaxis  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 1/513 (0.19%)  1 0/141 (0.00%)  0 0/213 (0.00%)  0
Hypoxia  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 1/513 (0.19%)  1 0/141 (0.00%)  0 0/213 (0.00%)  0
Pleural effusion  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 0/513 (0.00%)  0 1/141 (0.71%)  1 0/213 (0.00%)  0
Respiratory arrest  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 0/513 (0.00%)  0 1/141 (0.71%)  1 0/213 (0.00%)  0
Vascular disorders                     
Arterial occlusive disease  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 1/513 (0.19%)  1 0/141 (0.00%)  0 0/213 (0.00%)  0
1
Term from vocabulary, MedDRA 24.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
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 (28.21%)      29/101 (28.71%)      26/107 (24.30%)      24/101 (23.76%)      23/112 (20.54%)      72/518 (13.90%)      92/776 (11.86%)      61/513 (11.89%)      17/141 (12.06%)      14/213 (6.57%)    
Blood and lymphatic system disorders                     
Anaemia  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 1/776 (0.13%)  1 4/513 (0.78%)  4 0/141 (0.00%)  0 2/213 (0.94%)  2
Leukopenia  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 1/513 (0.19%)  1 0/141 (0.00%)  0 0/213 (0.00%)  0
Lymphopenia  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 1/776 (0.13%)  1 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Microcytic anaemia  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 0/513 (0.00%)  0 1/141 (0.71%)  1 0/213 (0.00%)  0
Monocytopenia  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 1/518 (0.19%)  1 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Neutropenia  1  1/156 (0.64%)  1 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 1/518 (0.19%)  1 0/776 (0.00%)  0 2/513 (0.39%)  2 0/141 (0.00%)  0 0/213 (0.00%)  0
Thrombocytopenia  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 1/776 (0.13%)  1 1/513 (0.19%)  1 0/141 (0.00%)  0 0/213 (0.00%)  0
Thrombocytosis  1  0/156 (0.00%)  0 1/101 (0.99%)  1 1/107 (0.93%)  1 0/101 (0.00%)  0 1/112 (0.89%)  1 1/518 (0.19%)  1 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Cardiac disorders                     
Acute myocardial infarction  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 1/518 (0.19%)  1 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Angina pectoris  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 1/518 (0.19%)  1 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Atrial fibrillation  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 1/776 (0.13%)  1 0/513 (0.00%)  0 1/141 (0.71%)  1 0/213 (0.00%)  0
Palpitations  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 1/776 (0.13%)  1 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Tachycardia  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 1/776 (0.13%)  1 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Ventricular extrasystoles  1  1/156 (0.64%)  1 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 1/776 (0.13%)  1 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Ventricular tachycardia  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 1/776 (0.13%)  1 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Ear and labyrinth disorders                     
Ear pain  1  0/156 (0.00%)  0 1/101 (0.99%)  1 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 1/513 (0.19%)  1 0/141 (0.00%)  0 0/213 (0.00%)  0
Vertigo  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 1/101 (0.99%)  1 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Eye disorders                     
Blepharitis  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 1/513 (0.19%)  1 0/141 (0.00%)  0 0/213 (0.00%)  0
Blepharospasm  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 1/101 (0.99%)  1 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Cataract  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 2/513 (0.39%)  2 0/141 (0.00%)  0 0/213 (0.00%)  0
Cataract nuclear  1  1/156 (0.64%)  1 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Diplopia  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 1/518 (0.19%)  1 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Eye pain  1  1/156 (0.64%)  1 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Eye paraesthesia  1  0/156 (0.00%)  0 1/101 (0.99%)  1 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Eyelids pruritus  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 1/776 (0.13%)  1 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Photophobia  1  0/156 (0.00%)  0 1/101 (0.99%)  1 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Retinal vein occlusion  1  1/156 (0.64%)  1 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Retinopathy hypertensive  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 1/513 (0.19%)  1 0/141 (0.00%)  0 0/213 (0.00%)  0
Vision blurred  1  0/156 (0.00%)  0 1/101 (0.99%)  1 0/107 (0.00%)  0 1/101 (0.99%)  1 0/112 (0.00%)  0 0/518 (0.00%)  0 1/776 (0.13%)  1 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Visual impairment  1  1/156 (0.64%)  1 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Vitreous haemorrhage  1  1/156 (0.64%)  1 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Xanthopsia  1  1/156 (0.64%)  1 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Gastrointestinal disorders                     
Abdominal discomfort  1  0/156 (0.00%)  0 1/101 (0.99%)  1 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Abdominal distension  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 1/101 (0.99%)  1 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Abdominal pain  1  1/156 (0.64%)  1 0/101 (0.00%)  0 1/107 (0.93%)  1 1/101 (0.99%)  1 1/112 (0.89%)  1 1/518 (0.19%)  1 1/776 (0.13%)  1 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Abdominal pain lower  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 0/776 (0.00%)  0 1/513 (0.19%)  1 0/141 (0.00%)  0 0/213 (0.00%)  0
Abdominal pain upper  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 2/776 (0.26%)  2 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Aphthous ulcer  1  0/156 (0.00%)  0 0/101 (0.00%)  0 1/107 (0.93%)  1 0/101 (0.00%)  0 0/112 (0.00%)  0 1/518 (0.19%)  1 0/776 (0.00%)  0 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Colitis  1  0/156 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/101 (0.00%)  0 0/112 (0.00%)  0 0/518 (0.00%)  0 1/776 (0.13%)  1 0/513 (0.00%)  0 0/141 (0.00%)  0 0/213 (0.00%)  0
Constipation  1 <