BLAZE-4: A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT04634409
Collaborator
AbCellera Biologics Inc. (Industry), Shanghai Junshi Bioscience Co., Ltd. (Other), GlaxoSmithKline (Industry), Vir Biotechnology, Inc. (Industry)
1,755
141
6
11.6
12.4
1.1

Study Details

Study Description

Brief Summary

The purpose of this study is to measure how well monoclonal antibodies work, either alone or in combination, against the virus that causes COVID-19. Study drug(s) will be given to participants with early symptoms of COVID-19. Samples will be taken from the back of the nose to determine how much virus is in the body at various times during the study. Participation could last about 12 or 24 weeks and includes at least 1 visit to the study site, with the remainder of assessments performed in the home, local clinic, or by phone.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
1755 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Includes open label arms
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Mono and Combination Therapy With Monoclonal Antibodies in Participants With Mild to Moderate COVID-19 Illness (BLAZE-4)
Actual Study Start Date :
Oct 29, 2020
Actual Primary Completion Date :
Jul 27, 2021
Actual Study Completion Date :
Oct 18, 2021

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo (Pbo)

Treatment 1: Pbo administered intravenously (IV). Treatment 8: Pbo For 700 mg Bamlanivimab (BAM) + 500 mg VIR-7831 (Amendment (C-e)) administered IV. Treatment 11: Pbo For 175 mg Bebtelovimab (BEB) & 700 mg BAM +1400 mg Etesevimab ( ETE) +175 mg BEB (Low Risk Participants) administered IV. Pooled Placebo (Addendum 4, IV) administered IV. Pooled Placebo (Addendum 4, SC) administered SC.

Drug: Placebo
Administered IV.

Experimental: BAM + ETE

Treatment 2: 175 mg BAM +350 mg ETE administered IV. Treatment 3: 700 mg BAM +1400 mg ETE administered IV. Treatment 4: 2800 mg BAM +2800 mg ETE administered IV. Treatment 6: 350 mg BAM +700 mg ETE administered IV. Unintentional Dosing: 700 mg BAM +700 mg ETE administered IV. 700 mg BAM + 1400 mg ETE 30-min (Addendum (2)) administered IV. 700 mg BAM + 1400 mg ETE 15-min (Addendum (2)) administered IV.

Drug: Bamlanivimab
Administered IV.
Other Names:
  • LY-CoV555
  • LY3819253
  • Drug: Etesevimab
    Administered IV.
    Other Names:
  • LY-CoV016
  • LY3832479
  • Experimental: BAM

    Treatment 5: 700 mg BAM administered IV. 700 mg BAM 15-min (Addendum (2)) administered IV.

    Drug: Bamlanivimab
    Administered IV.
    Other Names:
  • LY-CoV555
  • LY3819253
  • Experimental: BAM + VIR-7831

    Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) administered IV.

    Drug: Bamlanivimab
    Administered IV.
    Other Names:
  • LY-CoV555
  • LY3819253
  • Drug: VIR-7831
    Administered IV.
    Other Names:
  • GSK4182136
  • Experimental: BEB

    Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) administered IV. Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants) administered IV. 70 mg BEB 140 mg/Min (Addendum 4, IV) administered IV. 175 mg BEB 140 mg/Min (Addendum 4, IV) administered IV. 175 mg BEB 350 mg/Min (Addendum 4, IV) administered IV. 1750 mg BEB 350 mg/Min (Addendum 4, IV) administered IV. 280 mg BEB (Addendum 4, SC) administered SC. 560 mg BEB (Addendum 4, SC) administered SC.

    Drug: Bebtelovimab
    Administered IV.
    Other Names:
  • LY-CoV1404, LY3853113
  • Experimental: BAM+ ETE + BEB

    Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants) administered IV. Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants) administered IV. Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB(Amendment (g), High Risk, Updated Centers for Disease Control and Prevention (CDC) Criteria) administered IV. 175/700/1400 mg BAM + ETE + BEB 350 mg/Min (Addendum 4, IV) administered IV.

    Drug: Bamlanivimab
    Administered IV.
    Other Names:
  • LY-CoV555
  • LY3819253
  • Drug: Etesevimab
    Administered IV.
    Other Names:
  • LY-CoV016
  • LY3832479
  • Drug: Bebtelovimab
    Administered IV.
    Other Names:
  • LY-CoV1404, LY3853113
  • Outcome Measures

    Primary Outcome Measures

    1. Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Greater Than 5.27 [Day 7]

      Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Relevance Sequence Imputation (RSI). RSI is defined as follows: If Day 7 SARS-CoV-2 viral load is missing, then Day 7 will be imputed using data from the first available for Day 5, Day 3, Day 11, or Day 1.

    2. Treatment 7-8, Amendments (C-e): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 [Day 7]

      Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).

    3. Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 [Day 7]

      Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).

    Secondary Outcome Measures

    1. Treatment 12 -13, Amendment (f) High Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 [Day 7]

      Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).

    2. Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 [Day 7]

      Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).

    3. Addendum (2): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 [Day 7]

      Missing data is estimated using Relevance Sequence Imputation (RSI). RSI is defined as follows: If Day 7 SARS-CoV-2 viral load is missing, then Day 7 will be imputed using data from the first available for Day 5, Day 3, Day 11, or Day 1.

    4. Addendum (4), Arm A - Intravenous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 [Day 7]

      Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).

    5. Addendum (4) Arm B - Subcutaneous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 [Day 7]

      Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).

    6. Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause [Baseline through Day 29]

      Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death from any Cause

    7. Treatment 7-8, Amendment (C-E): Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause [Baseline through Day 29]

      Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death from Any Cause

    8. Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause [Baseline through Day 29]

      Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause

    9. Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause [Baseline through Day 29]

      Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause

    10. Treatment 14 Amendment (f) High Risk Participants, Updated CDC Criteria: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause [Baseline through Day 29]

      Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause

    11. Treatment 1-6 and Unintentional Dosing Arms: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load [Baseline, Day 7]

      Least squares mean (LSM) change from baseline was calculated using a mixed model repeating measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. Viral load is reported as normalized viral and is unitless.

    12. Treatment 7-8 Amendments (C-e): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load [Baseline, Day 7]

      LSM change from baseline was calculated using a MMRM that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. Viral load is reported as normalized viral and is unitless.

    13. Treatment 9-11 Amendment (f), Low Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load [Baseline, Day 7]

      LSM change from baseline was calculated using a MMRM that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. Viral load is reported as normalized viral and is unitless.

    14. Treatment 12 -13 Amendment (f), High Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load [Baseline, Day 7]

      Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.

    15. Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load [Baseline, Day 7]

      Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.

    16. Addendum 4, IV: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load [Baseline, Day 7]

      Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.

    17. Addendum 4, SC: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load [Baseline, Day 7]

      Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.

    18. Addendum (2): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load [Baseline, Day 7]

      Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.

    19. Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Resolution [Day 7]

      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 loss in taste and smell. Each symptom (excluding loss of taste and smell) 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). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom resolution (yes/no) is defined as all symptoms (excluding loss of appetite, taste, and smell) on the symptom questionnaire scored as absent (score of 0). Missing data was imputed using a non-responder imputation.

    20. Treatment 7-8 Amendments (C-e): Percentage of Participants Demonstrating Symptom Resolution [Day 7]

      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 loss in taste and smell. Each symptom (excluding loss of taste and smell) 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). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom resolution (yes/no) is defined as all symptoms (excluding loss of appetite, taste, and smell) on the symptom questionnaire scored as absent (score of 0). Missing data was imputed using a non-responder imputation.

    21. Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Demonstrating Symptom Resolution [Day 7]

      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 loss in taste and smell. Each symptom (excluding loss of taste and smell) 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). Loss of taste and smell was scored as Yes (Y) or No (N). 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. Missing data was imputed using a non-responder imputation.

    22. Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Resolution [Day 7]

      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 loss in taste and smell. Each symptom (excluding loss of taste and smell) 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). Loss of taste and smell was scored as Yes (Y) or No (N). 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. Missing data was imputed using a non-responder imputation.

    23. Treatment 14, Amendment (g) High Risk Participants Updated CDC Criteria Amendment (g): Percentage of Participants Demonstrating Symptom Resolution [Day 7]

      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 loss in taste and smell. Each symptom (excluding loss of taste and smell) 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). Loss of taste and smell was scored as Yes (Y) or No (N). 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. Missing data was imputed using a non-responder imputation.

    24. Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Improvement [Day 7]

      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 loss in taste and smell. Each symptom (excluding loss of taste and smell) 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). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.

    25. Treatment 7-8 Amendments (C-E): Percentage of Participants Demonstrating Symptom Improvement [Day 7]

      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 loss in taste and smell. Each symptom (excluding loss of taste and smell) 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). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.

    26. Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Demonstrating Symptom Improvement [Day 7]

      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 loss in taste and smell. Each symptom (excluding loss of taste and smell) 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). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.

    27. Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Improvement [Day 7]

      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 loss in taste and smell. Each symptom (excluding loss of taste and smell) 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). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.

    28. Treatment 14 Amendment (g): Percentage of Participants Demonstrating Symptom Improvement [Day 7]

      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 loss in taste and smell. Each symptom (excluding loss of taste and smell) 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). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.

    29. Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause [Baseline through Day 29]

      Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

    30. Treatment 7-8 Amendments (C-E): Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause [Baseline through Day 29]

      Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

    31. Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause [Baseline through Day 29]

      Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

    32. Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause [Baseline through Day 29]

      Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

    33. Treatment 14 Amendment (g): Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause [Baseline through Day 29]

      Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

    34. Pharmacokinetics (PK): Mean Concentration of Bamlanivimab [Day 29]

      PK: Mean Concentration of Bamlanivimab

    35. Pharmacokinetics (PK): Mean Concentration of Etesevimab [Day 29]

      Pharmacokinetics (PK): Mean Concentration of Etesevimab

    36. Pharmacokinetics (PK): Mean Concentration of Bebtelovimab [Day 29]

      Pharmacokinetics (PK): Mean Concentration of Bebtelovimab

    37. Pharmacokinetics (PK): Mean Concentration of VIR-7831 [Day 29]

      PK: Mean Concentration of VIR-7831

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • For low-risk participant arms 9-11 only: Are greater than or equal to (≥)18 and less than (<)65 years of age at the time of randomization and do not have the risk factors defined in the bullet point directly below

    • For high-risk participant arms 12 and 13 only:

    -- Are ≥18 years of age and satisfy at least one of the following risk factors at the time of screening

    • Are ≥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

    • For high-risk participant arms 12 and 13 only:

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

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

    • Have sickle cell disease

    • Have congenital or acquired heart disease

    • Have neurodevelopmental disorders, for example, cerebral palsy

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

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

    • Have type 1 or type 2 diabetes

    • Have chronic kidney disease

    • Have immunosuppressive disease, or

    • Are currently receiving immunosuppressive treatment.

    For high-risk participants arm 14 only:
    • Are ≥12 years of age and satisfy at least one of the following risk factors at the time of screening Are ≥65 years of age

    • Are adults (≥18 years of age) with BMI >25 kg/m2 , or if age 12-17, have BMI ≥85th percentile for their age and gender based on CDC growth charts

    • Have chronic kidney disease

    • Have type 1 or type 2 diabetes

    • Have immunosuppressive disease

    • Are currently receiving immunosuppressive treatment

    • Have cardiovascular disease (including congenital heart disease) or hypertension

    • Have chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension)

    • Have sickle cell disease

    • Have neurodevelopmental disorder (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)

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

    • Are currently not hospitalized

    • Have one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion, nasal congestion or runny nose, new loss of smell, chills

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

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

    • Understand and agree to comply with planned study procedures

    • Agree to the collection of nasopharyngeal swabs and venous blood

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

    Exclusion Criteria:
    • For low-risk participants only: BMI ≥35

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

    • Require mechanical ventilation or anticipated impending need for mechanical ventilation

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

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

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

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

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

    • Have a history of a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test prior to the one serving as eligibility for this study

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

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

    • Have a history of convalescent COVID-19 plasma treatment

    • For low-risk arms only: have received a SARS-CoV-2 vaccine or have participated in a previous SARS-CoV-2 vaccine study and are currently blinded to treatment allotment

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

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

    • Are pregnant or breast feeding

    • Are investigator site personnel directly affiliated with this study

    • Have body weight <40 kilograms

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35233
    2 The Institute for Liver Health Mesa Arizona United States 85210
    3 Perseverance Research Center Scottsdale Arizona United States 85254
    4 CRI of Arizona, LLC Sun City West Arizona United States 85375
    5 Fiel Family and Sports Medicine PC Tempe Arizona United States 85283
    6 The Institute for Liver Health Tucson Arizona United States 85712
    7 KLR Business Group, Inc. dba Arkansas Clinical Research Little Rock Arkansas United States 72205
    8 Applied Rsch Ctr - Arkansas Inc. Little Rock Arkansas United States 72212
    9 Smart Cures Clin Research Anaheim California United States 92806
    10 Hope Clinical Research Canoga Park California United States 91303
    11 VCT-Covina Covina California United States 91723
    12 Neighborhood Healthcare Escondido California United States 92025
    13 Chemidox Clinical Trials Lancaster California United States 93534
    14 Ark Clinical Research Long Beach California United States 90806
    15 Long Beach Clinical Trials LLC Long Beach California United States 90806
    16 Cedars Sinai Medical Center Los Angeles California United States 90048-5615
    17 Central Valley Research, LLC Modesto California United States 95350
    18 Inland Empire Liver Foundation Rialto California United States 92377
    19 Sutter Institute For Medical Research Sacramento California United States 95816
    20 Wolverine Clinical Trials, LLC Santa Ana California United States 92705
    21 St. Joe Heritage HC-Santa Rosa Santa Rosa California United States 95405
    22 Stanford University Hospital Stanford California United States 94305
    23 Mazur, Statner, Dutta, Nathan Thousand Oaks California United States 91360
    24 South Bay Clinical Research Institute Torrance California United States 90503
    25 Infect Disease Doctors Med Grp Walnut Creek California United States 94598
    26 Allianz Research Institute Westminster California United States 92683
    27 Future Innovative Treatments LLC Colorado Springs Colorado United States 80907
    28 Georgetown Univ Sch of Med Washington District of Columbia United States 20007
    29 Synergy Healthcare LLC Bradenton Florida United States 34208
    30 Holy Cross Hospital Inc. Fort Lauderdale Florida United States 33308
    31 I R & Health Center, Inc. Hialeah Florida United States 33012
    32 Encore Medical Research Hollywood Florida United States 33021
    33 Elixia CRC Hollywood Florida United States 33023
    34 Lakeland Regional Medical Center Lakeland Florida United States 33804
    35 Panax Clinical Research Miami Lakes Florida United States 33014
    36 Hope Clinical Trials, Inc. Miami Florida United States 33165
    37 Miami Cancer Institute at Baptist Health, Inc. Miami Florida United States 33176
    38 Bio-Medical Research, LLC Miami Florida United States 33184
    39 Clinical Site Partners, LLC d/b/a CSP Miami Miami Florida United States 33186
    40 Testing Matters Lab Sunrise Florida United States 33325
    41 Advent Health Tampa Tampa Florida United States 33613
    42 Triple O Research Inst West Palm Beach Florida United States 33407
    43 Encore Medical Research - Weston Weston Florida United States 33331
    44 Clinical Site Partners, LLC DBA CSP Orlando Winter Park Florida United States 32789
    45 Gwinnett Research Inst Buford Georgia United States 30519
    46 Paramount Rch Sol - College Pk College Park Georgia United States 30349
    47 IACT Health - VHC Columbus Georgia United States 31904
    48 Central Georgia Infectious Disease Macon Georgia United States 31201
    49 Rophe Adult and Pediatric Medicine Union City Georgia United States 30291
    50 Rocky Mountain Clinical Research Idaho Falls Idaho United States 83404
    51 Ann & Robert H Lurie Children's Hospital of Chicago Chicago Illinois United States 60611
    52 Great Lakes Clinical Trials Chicago Illinois United States 60640
    53 Franciscan Health Hammond Dyer Indiana United States 46311
    54 Qualmedica Research Evansville Evansville Indiana United States 47715
    55 Franciscan St. Francis Health Indianapolis Indiana United States 46237
    56 St.Vincent - Indy Indianapolis Indiana United States 46260
    57 Qualmedica Research, LLC Owensboro Kentucky United States 42301
    58 Tandem Clinical Research,LLC Marrero Louisiana United States 70072
    59 Imperial Health Urgent Care Center - Moss Bluff Moss Bluff Louisiana United States 70611
    60 Nola Research Works, LLC New Orleans Louisiana United States 70125
    61 University of Maryland Medical Center Baltimore Maryland United States 21201
    62 Massachusetts General Hospital Boston Massachusetts United States 02114
    63 U of MA Mem Med Ctr Worcester Massachusetts United States 01605
    64 University of Michigan Ann Arbor Michigan United States 48109
    65 Great Lakes Research Group, Inc. Bay City Michigan United States 48706
    66 Revive Research Institute Farmington Hills Michigan United States 48334
    67 Revival Research Institute Sterling Heights Michigan United States 48312
    68 Sky Clinical Prime and Health Wellness Clinic Fayette Mississippi United States 39069
    69 Olive Branch Family Medical Center Olive Branch Mississippi United States 38654
    70 Sky Clin Resch - Quinn HC Ridgeland Mississippi United States 39157
    71 Bio-Kinetic Clinical Applications, LLC Springfield Missouri United States 65802
    72 Quality Clinical Research Omaha Nebraska United States 68114
    73 Excel Clinical Research Las Vegas Nevada United States 89109
    74 Las Vegas Medical Research Las Vegas Nevada United States 89113
    75 SVG Clinical Las Vegas Nevada United States 89128
    76 Holy Name Medical Center Teaneck New Jersey United States 07666
    77 Prime Global Research, LLC Bronx New York United States 10456
    78 Onsite Clinical Solutions, LLC Charlotte North Carolina United States 28226
    79 East Carolina University Greenville North Carolina United States 27834
    80 Monroe Biomed Research Monroe North Carolina United States 28112
    81 Carteret Medical Group Morehead City North Carolina United States 28557
    82 PMG Research of Wilmington Wilmington North Carolina United States 28401
    83 Valley Medical Primary Care Centerville Ohio United States 45459
    84 Hometown UC and Rch- Cincy Cincinnati Ohio United States 45215
    85 Aventiv Research Inc Columbus Ohio United States 43213
    86 Urgent Care Specialists, LLC Columbus Ohio United States 43214
    87 Remington-Davis, Inc Columbus Ohio United States 43215
    88 Urgent Care Specialists, LLC Dayton Ohio United States 45424
    89 META Medical Research Institute Dayton Ohio United States 45432
    90 Ascension St. John Tulsa OK Tulsa Oklahoma United States 74104
    91 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 18901
    92 Jefferson Hosp for Neurosci Philadelphia Pennsylvania United States 19107
    93 Temple University Hospital Philadelphia Pennsylvania United States 19140
    94 VITALINK - Anderson Anderson South Carolina United States 29621
    95 Carolina Medical Research - Clinton Clinton South Carolina United States 29325
    96 VITALINK - Gaffney Gaffney South Carolina United States 29340
    97 Carolina Medical Research - Greenville Greenville South Carolina United States 29607
    98 VITALINK - Greenville Greenville South Carolina United States 29615
    99 VITALINK - Spartanburg Spartanburg South Carolina United States 29303
    100 VITALINK - Union Union South Carolina United States 29379
    101 Univ Diab & Endo Consult Chattanooga Tennessee United States 37411
    102 New Phase Research and Development Knoxville Tennessee United States 37909
    103 Gadolin Research, LLC Beaumont Texas United States 77702
    104 Conroe Willis Medical Research Conroe Texas United States 77304
    105 Crossroads Clinical Research Corpus Christi Texas United States 78413
    106 B S & W Med Center Dallas Texas United States 75246
    107 Baylor - Fort Worth Fort Worth Texas United States 76104
    108 North Texas Clinical Trials, LLC Fort Worth Texas United States 76104
    109 Houston Methodist Research Ins Houston Texas United States 77030
    110 Next Level Urgent Care Houston Texas United States 77057
    111 Accurate Clinical Management, LLC. Houston Texas United States 77065
    112 1960 Family Practice, PA Houston Texas United States 77090
    113 B S & W Med Center Irving Texas United States 75061
    114 Zion Urgent Care Clinic Katy Texas United States 77494
    115 BioPharma Family Practice Center McAllen McAllen Texas United States 78501
    116 BRCR Medical Center, Inc McAllen Texas United States 78501
    117 North Hills Medical Research North Richland Hills Texas United States 76180
    118 Bay Area Infectious Diseases Associates Pasadena Texas United States 77505
    119 Epic Medical Research Red Oak Texas United States 75154
    120 Baylor - Round Rock Round Rock Texas United States 78665
    121 Sun Research Institute San Antonio Texas United States 78215
    122 Consano Clinical Research, LLC Shavano Park Texas United States 78231
    123 APD Clinical Research Splendora Texas United States 77372
    124 Crossroads Clin Rch-Victoria Victoria Texas United States 77901
    125 CLS Research Ctr, PLLC Webster Texas United States 77598
    126 CARE ID Annandale Virginia United States 22003
    127 Evergreen Health Research Kirkland Washington United States 98034
    128 Sanatorio Sagrado Corazón Ciudad de Buenos Aires AR Argentina C1039AAC
    129 Clínica Zabala Ciudad de Buenos Aires AR Argentina C1426AAM
    130 Sanatorio de la Trinidad Mitre Caba Buenos Aires Argentina C1039AAO
    131 Clínica Privada Independencia Munro Buenos Aires Argentina
    132 Go Centro Medico San Nicolás San Nicolás Buenos Aires Argentina B2900DPA
    133 Instituto de Investigaciones Clinicas Zarate Zárate Buenos Aires Argentina 2800
    134 Instituto Médico Rio Cuarto Rio Cuarto Cordoba Argentina X5800AEV
    135 Clinica Central S.A. Villa Regina Rio Negro Argentina R8336
    136 Centro de Investigaciones Clínicas - Clínica Viedma Viedma RN Argentina 8500
    137 INECO Neurociencias Oroño Rosario Santa Fe Argentina S2000
    138 Hospital San Roque Cordoba Argentina 5000
    139 Advanced Clinical Research, LLC Bayamon Puerto Rico 00961
    140 Dorado Medical Complex Inc Dorado Puerto Rico 00646
    141 GCM Medical Group, PSC - Hato Rey Site San Juan Puerto Rico 00917

    Sponsors and Collaborators

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

    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)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT04634409
    Other Study ID Numbers:
    • 18160
    • J2X-MC-PYAH
    First Posted:
    Nov 18, 2020
    Last Update Posted:
    Jul 1, 2022
    Last Verified:
    Jun 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
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Treatment 1: Pbo Treatment 2: 175 mg BAM +350 mg ETE Treatment 3: 700 mg BAM +1400 mg ETE Treatment 4: 2800 mg BAM +2800 mg ETE Treatment 5: 700 mg BAM Treatment 6: 350 mg BAM +700 mg ETE Unintentional Dosing: 700 mg BAM +700 mg ETE Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants) Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants) Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants) Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants) Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB(Amendment (g), High Risk,Updated CDC Criteria) 700 mg BAM 15-min (Addendum (2)) 700 mg BAM + 1400 mg ETE 30-min (Addendum (2)) 700 mg BAM + 1400 mg ETE 15-min (Addendum (2)) Pooled Placebo (Addendum 4, IV) 70 mg BEB 140 mg/Min (Addendum 4, IV) 175 mg BEB 140 mg/Min (Addendum 4, IV) 175 mg BEB 350 mg/Min (Addendum 4, IV) 175/700/1400 mg BAM + ETE + BEB 350 mg/Min (Addendum 4, IV) 1750 mg BEB 350 mg/Min (Addendum 4, IV) Pooled Placebo (Addendum 4, SC) 280 mg BEB (Addendum 4, SC) 560 mg BEB (Addendum 4, SC)
    Arm/Group Description Participants received placebo (Pbo) administered intravenously (IV). Participants received 175 milligrams (mg) bamlanivimab (BAM) +350 mg etesevimab (ETE) administered IV. Participants received 700 mg BAM +1400 mg ETE administered IV. Participants received 2800 mg BAM + 2800 mg ETE administered IV. Participants received 700 mg BAM administered IV. Participants received 350 mg BAM +700 mg ETE administered IV. Participants received 700 mg BAM +700 mg ETE administered IV. Participants received 700 mg BAM + 500 mg VIR-7831 administered IV. Participants received placebo administered IV. Amendment (f) Low Risk Participants: Participants received 175 mg bebtelovimab (BEB) administered IV. Amendment (f) Low Risk Participants: Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV. Amendment (f) Low Risk Participants: Participants received placebo administered IV. Amendment (f) High Risk Participants: Participants received 175 mg BEB administered IV. Amendment (f) High Risk Participants: Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV. Amendment (g), High Risk, Updated CDC Criteria): Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV for participants in updated CDC criteria. Participants received 700 mg BAM administered IV. Addendum 2 explored the safety of accelerated intravenous (IV) administration of BAM alone and in combination with ETE. Participants received 700 mg BAM +1400 mg ETE administered IV. Addendum 2 explored the safety of accelerated intravenous (IV) administration of BAM alone and in combination with ETE. Participants received 700 mg BAM +1400 mg ETE administered IV. Addendum 2 explored the safety of accelerated intravenous (IV) administration of BAM alone and in combination with ETE. Participants received placebo administered IV. Participants received 70 mg BEB 140 mg/min IV. Participants received 175 mg BEB 140 mg/min IV. Participants received 175 mg BEB 350 mg/min IV. Participants received 175 mg BAM + 700 mg ETE + 1400 mg BEB 350 mg/min IV. Participants received 1750 mg BEB 350 mg/min IV. Participants received Placebo SC. Participants received 280 mg BEB SC. Participants received 560 mg BEB SC.
    Period Title: Overall Study
    STARTED 155 83 158 103 105 101 20 101 101 125 127 128 100 50 176 30 6 30 10 6 6 6 6 6 4 6 6
    Received at Least One Dose of Study Drug 155 83 158 103 105 101 20 101 101 125 127 128 100 50 176 30 6 30 10 6 6 6 6 6 4 6 6
    COMPLETED 148 81 150 96 102 99 19 90 91 112 114 109 92 46 164 30 6 29 10 6 6 6 6 5 4 6 6
    NOT COMPLETED 7 2 8 7 3 2 1 11 10 13 13 19 8 4 12 0 0 1 0 0 0 0 0 1 0 0 0

    Baseline Characteristics

    Arm/Group Title Treatment 1: Pbo Treatment 2: 175 mg BAM +350 mg ETE Treatment 3: 700 mg BAM +1400 mg ETE Treatment 4: 2800 mg BAM +2800 mg ETE Treatment 5: 700 mg BAM Treatment 6: 350 mg BAM +700 mg ETE Unintentional Dosing: 700 mg Bamlanivimab +700 mg Etesevimab Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants) Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants) Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants) Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants) Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB (Amendment (g), Updated CDC Criteria) 700 mg BAM 15-min (Addendum (2)) 700 mg BAM + 1400 mg ETE 30-min (Addendum (2)) 700 mg BAM + 1400 mg ETE 15-min (Addendum (2)) Pooled Placebo (Addendum 4, IV) 70 mg BEB 140 mg/Min (Addendum 4, IV) 175 mg BEB 140 mg/Min (Addendum 4, IV) 175 mg BEB 350 mg/Min (Addendum 4, IV) 175/700/1400 mg BAM + ETE + BEB 350 mg/Min (Addendum 4, IV) 1750 mg BEB 350 mg/Min (Addendum 4, IV) Pooled Placebo (Addendum 4, SC) 280 BEB (Addendum 4, SC) 560 mg BEB (Addendum 4, SC) Total
    Arm/Group Description Participants received placebo (Pbo) administered intravenously (IV). Participants received 175 milligrams (mg) bamlanivimab (BAM) +350 mg etesevimab (ETE) administered IV. Participants received 700 mg BAM +1400 mg ETE administered IV. Participants received 2800 mg BAM + 2800 mg ETE administered IV. Participants received 700 mg BAM administered IV. Participants received 350 mg BAM +700 mg ETE administered IV. Participants received 700 mg bamlanivimab +700 mg etesevimab administered IV. Participants received 700 mg BAM + 500 mg VIR-7831 administered IV. Participants received placebo administered IV. Amendment (f) Low Risk Participants: Participants received 175 mg BEB administered IV. Amendment (f) Low Risk Participants: Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV Amendment (f) Low Risk Participants: Participants received placebo administered IV. Amendment (f) High Risk Participants: Participants received 175 mg BEB administered IV. Amendment (f) High Risk Participants: Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV. Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV for participants in updated CDC criteria. Participants received 700 mg BAM administered IV. Addendum 2 explored the safety of accelerated intravenous (IV) administration of BAM alone and in combination with ETE. Participants received 700 mg BAM +1400 mg ETE administered IV. Addendum 2 explored the safety of accelerated intravenous (IV) administration of BAM alone and in combination with ETE. Participants received 700 mg BAM +1400 mg ETE administered IV. Addendum 2 explored the safety of accelerated intravenous (IV) administration of BAM alone and in combination with ETE. Participants received placebo administered IV. Participants received 70 mg BEB 140 mg/min IV. Participants received 175 mg BEB 140 mg/min IV. Participants received 175 mg BEB 350 mg/min IV. Participants received 175 mg BAM + 700 mg ETE + 1400 mg BEB 350 mg/min IV. Participants received 1750 mg BEB 350 mg/min IV. Participants received Placebo SC. Participants received 280 mg BEB SC. Participants received 560 mg BEB SC. Total of all reporting groups
    Overall Participants 155 83 158 103 105 101 20 101 101 125 127 128 100 50 176 30 6 30 10 6 6 6 6 6 4 6 6 1755
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    38.9
    (12.22)
    41.5
    (12.89)
    37.7
    (12.11)
    39.5
    (12.63)
    39.8
    (12.70)
    42.3
    (11.93)
    36.5
    (15.04)
    37.6
    (12.83)
    38.9
    (11.77)
    36.2
    (11.40)
    37.6
    (12.12)
    36.1
    (11.66)
    49.1
    (15.17)
    50.8
    (17.06)
    49.3
    (17.39)
    35.4
    (12.55)
    47.7
    (7.28)
    42.9
    (11.87)
    46.8
    (13.27)
    35.2
    (13.99)
    48.7
    (9.83)
    36.3
    (15.24)
    41.7
    (14.76)
    39.5
    (16.88)
    30.0
    (6.98)
    35.8
    (7.08)
    39.2
    (9.70)
    40.6
    (13.89)
    Sex: Female, Male (Count of Participants)
    Female
    75
    48.4%
    39
    47%
    86
    54.4%
    55
    53.4%
    50
    47.6%
    48
    47.5%
    8
    40%
    52
    51.5%
    56
    55.4%
    63
    50.4%
    76
    59.8%
    72
    56.3%
    52
    52%
    26
    52%
    98
    55.7%
    12
    40%
    3
    50%
    13
    43.3%
    3
    30%
    3
    50%
    6
    100%
    1
    16.7%
    3
    50%
    5
    83.3%
    1
    25%
    1
    16.7%
    2
    33.3%
    909
    51.8%
    Male
    80
    51.6%
    44
    53%
    72
    45.6%
    48
    46.6%
    55
    52.4%
    53
    52.5%
    12
    60%
    49
    48.5%
    45
    44.6%
    62
    49.6%
    51
    40.2%
    56
    43.8%
    48
    48%
    24
    48%
    78
    44.3%
    18
    60%
    3
    50%
    17
    56.7%
    7
    70%
    3
    50%
    0
    0%
    5
    83.3%
    3
    50%
    1
    16.7%
    3
    75%
    5
    83.3%
    4
    66.7%
    846
    48.2%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    48
    31%
    24
    28.9%
    47
    29.7%
    28
    27.2%
    28
    26.7%
    33
    32.7%
    3
    15%
    18
    17.8%
    27
    26.7%
    46
    36.8%
    45
    35.4%
    45
    35.2%
    19
    19%
    8
    16%
    49
    27.8%
    15
    50%
    1
    16.7%
    3
    10%
    3
    30%
    0
    0%
    0
    0%
    1
    16.7%
    1
    16.7%
    2
    33.3%
    0
    0%
    1
    16.7%
    2
    33.3%
    497
    28.3%
    Not Hispanic or Latino
    104
    67.1%
    57
    68.7%
    108
    68.4%
    70
    68%
    74
    70.5%
    66
    65.3%
    17
    85%
    80
    79.2%
    72
    71.3%
    78
    62.4%
    82
    64.6%
    83
    64.8%
    81
    81%
    42
    84%
    126
    71.6%
    15
    50%
    5
    83.3%
    26
    86.7%
    6
    60%
    6
    100%
    6
    100%
    5
    83.3%
    5
    83.3%
    4
    66.7%
    4
    100%
    2
    33.3%
    4
    66.7%
    1228
    70%
    Unknown or Not Reported
    3
    1.9%
    2
    2.4%
    3
    1.9%
    5
    4.9%
    3
    2.9%
    2
    2%
    0
    0%
    3
    3%
    2
    2%
    1
    0.8%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    0.6%
    0
    0%
    0
    0%
    1
    3.3%
    1
    10%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    3
    50%
    0
    0%
    30
    1.7%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    2
    1.3%
    0
    0%
    1
    0.6%
    0
    0%
    1
    1%
    1
    1%
    0
    0%
    1
    1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    2%
    1
    2%
    4
    2.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    13
    0.7%
    Asian
    4
    2.6%
    4
    4.8%
    13
    8.2%
    3
    2.9%
    9
    8.6%
    4
    4%
    0
    0%
    4
    4%
    1
    1%
    1
    0.8%
    4
    3.1%
    2
    1.6%
    3
    3%
    1
    2%
    1
    0.6%
    0
    0%
    3
    50%
    3
    10%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    60
    3.4%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    2
    1.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    2%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    2%
    0
    0%
    1
    0.6%
    1
    3.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    8
    0.5%
    Black or African American
    7
    4.5%
    5
    6%
    6
    3.8%
    7
    6.8%
    4
    3.8%
    7
    6.9%
    2
    10%
    15
    14.9%
    5
    5%
    19
    15.2%
    19
    15%
    29
    22.7%
    14
    14%
    13
    26%
    28
    15.9%
    2
    6.7%
    0
    0%
    0
    0%
    1
    10%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    16.7%
    1
    16.7%
    185
    10.5%
    White
    132
    85.2%
    68
    81.9%
    127
    80.4%
    91
    88.3%
    85
    81%
    84
    83.2%
    17
    85%
    74
    73.3%
    90
    89.1%
    97
    77.6%
    99
    78%
    90
    70.3%
    78
    78%
    32
    64%
    136
    77.3%
    27
    90%
    3
    50%
    27
    90%
    9
    90%
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    4
    100%
    5
    83.3%
    5
    83.3%
    1410
    80.3%
    More than one race
    1
    0.6%
    0
    0%
    2
    1.3%
    0
    0%
    1
    1%
    0
    0%
    0
    0%
    1
    1%
    1
    1%
    0
    0%
    0
    0%
    1
    0.8%
    1
    1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    8
    0.5%
    Unknown or Not Reported
    9
    5.8%
    6
    7.2%
    7
    4.4%
    2
    1.9%
    5
    4.8%
    5
    5%
    1
    5%
    4
    4%
    4
    4%
    8
    6.4%
    5
    3.9%
    6
    4.7%
    0
    0%
    3
    6%
    6
    3.4%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    71
    4%
    Region of Enrollment (Count of Participants)
    United States
    155
    100%
    83
    100%
    158
    100%
    103
    100%
    105
    100%
    101
    100%
    20
    100%
    101
    100%
    101
    100%
    125
    100%
    127
    100%
    128
    100%
    100
    100%
    50
    100%
    176
    100%
    30
    100%
    6
    100%
    30
    100%
    10
    100%
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    4
    100%
    6
    100%
    6
    100%
    1755
    100%

    Outcome Measures

    1. Primary Outcome
    Title Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Greater Than 5.27
    Description Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Relevance Sequence Imputation (RSI). RSI is defined as follows: If Day 7 SARS-CoV-2 viral load is missing, then Day 7 will be imputed using data from the first available for Day 5, Day 3, Day 11, or Day 1.
    Time Frame Day 7

    Outcome Measure Data

    Analysis Population Description
    Treatment 1-6 and Unintentional Dosing arms: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
    Arm/Group Title Treatment 1: Pbo Treatment 2: 175 mg BAM +350 mg ETE Treatment 3: 700 mg BAM +1400 mg ETE Treatment 4: 2800 mg BAM +2800 mg ETE Treatment 5: 700 mg BAM Treatment 6: 350 mg BAM +700 mg ETE Unintentional Dosing: 700 mg BAM +700 mg ETE
    Arm/Group Description Participants received placebo (Pbo) administered intravenously (IV). Participants received 175 milligrams (mg) bamlanivimab (BAM) +350 mg etesevimab (ETE) administered IV. Participants received 700 mg BAM +1400 mg ETE administered IV. Participants received 2800 mg BAM + 2800 mg ETE administered IV. Participants received 700 mg BAM administered IV. Participants received 350 mg BAM +700 mg ETE administered IV. Participants received 700 mg BAM +700 mg ETE administered IV.
    Measure Participants 155 82 157 103 105 101 20
    Number (95% Confidence Interval) [percentage of participants]
    27.7
    17.9%
    12.2
    14.7%
    10.8
    6.8%
    7.8
    7.6%
    14.3
    13.6%
    7.9
    7.8%
    10.0
    50%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 2: 175 mg BAM +350 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.009273
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.37
    Confidence Interval (2-Sided) 95%
    0.18 to 0.78
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 3: 700 mg BAM +1400 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.000271
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.32
    Confidence Interval (2-Sided) 95%
    0.18 to 0.59
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 4: 2800 mg BAM +2800 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.000257
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.23
    Confidence Interval (2-Sided) 95%
    0.10 to 0.51
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 5: 700 mg BAM
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.013378
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.44
    Confidence Interval (2-Sided) 95%
    0.23 to 0.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 6: 350 mg BAM +700 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.000318
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.24
    Confidence Interval (2-Sided) 95%
    0.11 to 0.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Unintentional Dosing: 700 mg BAM +700 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.140563
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.35
    Confidence Interval (2-Sided) 95%
    0.09 to 1.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Primary Outcome
    Title Treatment 7-8, Amendments (C-e): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
    Description Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).
    Time Frame Day 7

    Outcome Measure Data

    Analysis Population Description
    Treatment 7-8, Amendments (C-e): All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
    Arm/Group Title Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))
    Arm/Group Description Participants received 700 mg BAM + 500 mg VIR-7831 administered IV. Participants received placebo administered IV.
    Measure Participants 101 101
    Number (95% Confidence Interval) [percentage of participants]
    9.9
    6.4%
    29.7
    35.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 2: 175 mg BAM +350 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.000835
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.27
    Confidence Interval (2-Sided) 95%
    0.12 to 0.58
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Primary Outcome
    Title Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
    Description Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).
    Time Frame Day 7

    Outcome Measure Data

    Analysis Population Description
    Treatment 9-11 Amendment (f), Low Risk Participants: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
    Arm/Group Title Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants) Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants)
    Arm/Group Description Amendment (f) Low Risk Participants: Participants received 175 mg BEB administered IV. Amendment (f) Low Risk Participants: Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV. Amendment (f) Low Risk Participants: Participants received placebo administered IV.
    Measure Participants 125 126 126
    Number (95% Confidence Interval) [percentage of participants]
    12.0
    7.7%
    12.7
    15.3%
    19.8
    12.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 3: 700 mg BAM +1400 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.097231
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.56
    Confidence Interval (2-Sided) 95%
    0.28 to 1.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Treatment 2: 175 mg BAM +350 mg ETE, Treatment 3: 700 mg BAM +1400 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.132360
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.59
    Confidence Interval (2-Sided) 95%
    0.30 to 1.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Treatment 12 -13, Amendment (f) High Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
    Description Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).
    Time Frame Day 7

    Outcome Measure Data

    Analysis Population Description
    Treatment 12 -13, Amendment (f) High Risk Participants: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
    Arm/Group Title Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants) Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants)
    Arm/Group Description Amendment (f) High Risk Participants: Participants received 175 mg BEB administered IV. Amendment (f) High Risk Participants: Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV.
    Measure Participants 99 50
    Number (95% Confidence Interval) [percentage of participants]
    25.3
    16.3%
    12.0
    14.5%
    5. Secondary Outcome
    Title Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
    Description Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).
    Time Frame Day 7

    Outcome Measure Data

    Analysis Population Description
    Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
    Arm/Group Title Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB(Amendment (g), High Risk,Updated CDC Criteria)
    Arm/Group Description Amendment (g), High Risk, Updated CDC Criteria): Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV for participants in updated CDC criteria.
    Measure Participants 176
    Number (95% Confidence Interval) [percentage of participants]
    17.6
    11.4%
    6. Secondary Outcome
    Title Addendum (2): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
    Description Missing data is estimated using Relevance Sequence Imputation (RSI). RSI is defined as follows: If Day 7 SARS-CoV-2 viral load is missing, then Day 7 will be imputed using data from the first available for Day 5, Day 3, Day 11, or Day 1.
    Time Frame Day 7

    Outcome Measure Data

    Analysis Population Description
    Addendum (2): All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
    Arm/Group Title 700 mg BAM 15-min (Addendum (2)) 700 mg BAM + 1400 mg ETE 30-min (Addendum (2)) 700 mg BAM + 1400 mg ETE 15-min (Addendum (2))
    Arm/Group Description Participants received 700 mg BAM administered IV. Addendum 2 explored the safety of accelerated intravenous (IV) administration of BAM alone and in combination with ETE. Participants received 700 mg BAM +1400 mg ETE administered IV. Addendum 2 explored the safety of accelerated intravenous (IV) administration of BAM alone and in combination with ETE. Participants received 700 mg BAM +1400 mg ETE administered IV. Addendum 2 explored the safety of accelerated intravenous (IV) administration of BAM alone and in combination with ETE.
    Measure Participants 30 6 30
    Number (95% Confidence Interval) [percentage of participants]
    16.7
    10.8%
    0.0
    0%
    13.3
    8.4%
    7. Secondary Outcome
    Title Addendum (4), Arm A - Intravenous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
    Description Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).
    Time Frame Day 7

    Outcome Measure Data

    Analysis Population Description
    Addendum (4) Arm A - Intravenous: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
    Arm/Group Title Pooled Placebo (Addendum 4, IV) 70 mg BEB 140 mg/Min (Addendum 4, IV) 175 BEB 140 mg/Min (Addendum 4, IV) 175 BEB 350 mg/Min (Addendum 4, IV) 175/700/1400 BAM+ETE+BEB 350mg/Min (Addendum 4, IV) 1750 BEB 350 mg/Min (Addendum 4, IV)
    Arm/Group Description Participants received placebo administered IV. Participants received 70 mg BEB 140 mg/min IV. Participants received 175 mg BEB 140 mg/min IV. Participants received 175 mg BEB 350 mg/min IV. Participants received 175 mg BAM + 700 mg ETE + 1400 mg BEB 350 mg/min IV. Participants received 1750 mg BEB 350 mg/min IV.
    Measure Participants 10 6 6 6 6 6
    Number (95% Confidence Interval) [percentage of participants]
    40.0
    25.8%
    16.7
    20.1%
    50.0
    31.6%
    0.0
    0%
    16.7
    15.9%
    33.3
    33%
    8. Secondary Outcome
    Title Addendum (4) Arm B - Subcutaneous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
    Description Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).
    Time Frame Day 7

    Outcome Measure Data

    Analysis Population Description
    Addendum (4) Arm B - Subcutaneous: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
    Arm/Group Title Pooled Placebo (Addendum 4, SC) 280 mg BEB (Addendum 4, SC) 560 mg BEB (Addendum 4, SC)
    Arm/Group Description Participants received placebo administered SC. Participants received 280 mg BEB SC. Participants received 560 mg BEB SC.
    Measure Participants 4 6 6
    Number (95% Confidence Interval) [percentage of participants]
    25.0
    16.1%
    16.7
    20.1%
    0.0
    0%
    9. Secondary Outcome
    Title Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
    Description Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death from any Cause
    Time Frame Baseline through Day 29

    Outcome Measure Data

    Analysis Population Description
    Treatment 1-6 and Unintentional Dosing arms: All participants randomly assigned and who received any amount of study drug.
    Arm/Group Title Treatment 1: Pbo Treatment 2: 175 mg BAM +350 mg ETE Treatment 3: 700 mg BAM +1400 mg ETE Treatment 4: 2800 mg BAM +2800 mg ETE Treatment 5: 700 mg BAM Treatment 6: 350 mg BAM +700 mg ETE Unintentional Dosing: 700 mg Bamlanivimab +700 mg Etesevimab
    Arm/Group Description Participants received placebo (Pbo) administered intravenously (IV). Participants received 175 milligrams (mg) bamlanivimab (BAM) +350 mg etesevimab (ETE) administered IV. Participants received 700 mg BAM +1400 mg ETE administered IV. Participants received 2800 mg BAM + 2800 mg ETE administered IV. Participants received 700 mg BAM administered IV. Participants received 350 mg BAM +700 mg ETE administered IV. Participants received 700 mg bamlanivimab +700 mg etesevimab administered IV.
    Measure Participants 155 83 158 103 105 101 20
    Number (95% Confidence Interval) [percentage of participants]
    0.6
    0.4%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 2: 175 mg BAM +350 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.769
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.62
    Confidence Interval (2-Sided) 95%
    0.02 to 15.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 3: 700 mg BAM +1400 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.494
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.32
    Confidence Interval (2-Sided) 95%
    0.01 to 8.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 4: 2800 mg BAM +2800 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.671
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.50
    Confidence Interval (2-Sided) 95%
    0.02 to 12.51
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 5: 700 mg BAM
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.663
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.49
    Confidence Interval (2-Sided) 95%
    0.02 to 12.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 6: 350 mg BAM +700 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.680
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.51
    Confidence Interval (2-Sided) 95%
    0.02 to 12.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Unintentional Dosing: 700 mg BAM +700 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.584
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.51
    Confidence Interval (2-Sided) 95%
    0.09 to 67.88
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Secondary Outcome
    Title Treatment 7-8, Amendment (C-E): Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
    Description Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death from Any Cause
    Time Frame Baseline through Day 29

    Outcome Measure Data

    Analysis Population Description
    Treatment 7-8, Amendment (C-E): All participants randomly assigned and who received any amount of study drug. No participants met the criteria (duration had to be 24 or more, and had to occur on Day 29 or before)
    Arm/Group Title Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))
    Arm/Group Description Participants received 700 mg BAM + 500 mg VIR-7831 administered IV. Participants received placebo administered IV.
    Measure Participants 0 0
    11. Secondary Outcome
    Title Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
    Description Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
    Time Frame Baseline through Day 29

    Outcome Measure Data

    Analysis Population Description
    Treatment 9-11 Amendment (f), Low Risk Participants: All randomized participants who received at least one dose of study drug.
    Arm/Group Title Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants) Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants)
    Arm/Group Description Amendment (f) Low Risk Participants: Participants received 175 mg BEB administered IV. Amendment (f) Low Risk Participants: Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV. Amendment (f) Low Risk Participants: Participants received placebo administered IV.
    Measure Participants 125 127 128
    Number (95% Confidence Interval) [percentage of participants]
    1.6
    1%
    2.4
    2.9%
    1.6
    1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 3: 700 mg BAM +1400 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.979
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.02
    Confidence Interval (2-Sided) 95%
    0.17 to 6.06
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Treatment 2: 175 mg BAM +350 mg ETE, Treatment 3: 700 mg BAM +1400 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.675
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.42
    Confidence Interval (2-Sided) 95%
    0.27 to 7.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    12. Secondary Outcome
    Title Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
    Description Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
    Time Frame Baseline through Day 29

    Outcome Measure Data

    Analysis Population Description
    Treatment 12 -13 Amendment (f), High Risk Participants: All randomized participants who received at least one dose of study drug.
    Arm/Group Title Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants)
    Arm/Group Description Amendment (f) High Risk Participants: Participants received 175 mg BEB administered IV. Amendment (f) High Risk Participants: Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV.
    Measure Participants 100 50
    Number (95% Confidence Interval) [percentage of participants]
    3.0
    1.9%
    4.0
    4.8%
    13. Secondary Outcome
    Title Treatment 14 Amendment (f) High Risk Participants, Updated CDC Criteria: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
    Description Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
    Time Frame Baseline through Day 29

    Outcome Measure Data

    Analysis Population Description
    Treatment 14 Amendment (f) High Risk, Participants Updated CDC Criteria: All randomized participants who received at least one dose of study drug.
    Arm/Group Title Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB (Amendment (g) High Risk,Updated CDC Criteria)
    Arm/Group Description Amendment (g), High Risk, Updated CDC Criteria): Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV for participants in updated CDC criteria.
    Measure Participants 176
    Number (95% Confidence Interval) [percentage of participants]
    1.7
    1.1%
    14. Secondary Outcome
    Title Treatment 1-6 and Unintentional Dosing Arms: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
    Description Least squares mean (LSM) change from baseline was calculated using a mixed model repeating measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. Viral load is reported as normalized viral and is unitless.
    Time Frame Baseline, Day 7

    Outcome Measure Data

    Analysis Population Description
    Treatment 1-6 and Unintentional Dosing Arms: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
    Arm/Group Title Treatment 1: Pbo Treatment 2: 175 mg BAM +350 mg ETE Treatment 3: 700 mg BAM +1400 mg ETE Treatment 4: 2800 mg BAM +2800 mg ETE Treatment 5: 700 mg BAM Treatment 6: 350 mg BAM +700 mg ETE Unintentional Dosing: 700 mg Bamlanivimab +700 mg Etesevimab
    Arm/Group Description Participants received placebo (Pbo) administered intravenously (IV). Participants received 175 milligrams (mg) bamlanivimab (BAM) +350 mg etesevimab (ETE) administered IV. Participants received 700 mg BAM +1400 mg ETE administered IV. Participants received 2800 mg BAM + 2800 mg ETE administered IV. Participants received 700 mg BAM administered IV. Participants received 350 mg BAM +700 mg ETE administered IV. Participants received 700 mg bamlanivimab +700 mg etesevimab administered IV.
    Measure Participants 135 71 138 92 93 81 17
    Least Squares Mean (Standard Error) [unitless]
    -2.87
    (0.149)
    -3.54
    (0.207)
    -3.52
    (0.148)
    -3.13
    (0.181)
    -3.28
    (0.180)
    -3.74
    (0.191)
    -3.51
    (0.419)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 2: 175 mg BAM +350 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.009
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSM Difference
    Estimated Value -0.67
    Confidence Interval (2-Sided) 95%
    -1.17 to -0.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 3: 700 mg BAM +1400 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSM Difference
    Estimated Value -0.65
    Confidence Interval (2-Sided) 95%
    -1.06 to -0.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 4: 2800 mg BAM +2800 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.263
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSM Difference
    Estimated Value -0.26
    Confidence Interval (2-Sided) 95%
    -0.72 to 0.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 5: 700 mg BAM
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.083
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSM Difference
    Estimated Value -0.41
    Confidence Interval (2-Sided) 95%
    -0.87 to 0.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 6: 350 mg BAM +700 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSM Difference
    Estimated Value -0.87
    Confidence Interval (2-Sided) 95%
    -1.35 to -0.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Unintentional Dosing: 700 mg BAM +700 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.149
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSM Difference
    Estimated Value -0.64
    Confidence Interval (2-Sided) 95%
    -1.52 to 0.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    15. Secondary Outcome
    Title Treatment 7-8 Amendments (C-e): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
    Description LSM change from baseline was calculated using a MMRM that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. Viral load is reported as normalized viral and is unitless.
    Time Frame Baseline, Day 7

    Outcome Measure Data

    Analysis Population Description
    Treatment 7-8 Amendments (c-e): All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
    Arm/Group Title Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))
    Arm/Group Description Participants received 700 mg BAM + 500 mg VIR-7831 administered IV. Participants received placebo administered IV.
    Measure Participants 96 94
    Least Squares Mean (Standard Error) [unitless]
    -3.56
    (0.182)
    -2.74
    (0.184)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 2: 175 mg BAM +350 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSM Difference
    Estimated Value -0.82
    Confidence Interval (2-Sided) 95%
    -1.33 to -0.31
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    16. Secondary Outcome
    Title Treatment 9-11 Amendment (f), Low Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
    Description LSM change from baseline was calculated using a MMRM that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. Viral load is reported as normalized viral and is unitless.
    Time Frame Baseline, Day 7

    Outcome Measure Data

    Analysis Population Description
    Treatment 9-11 Amendment (f), Low Risk Participants: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
    Arm/Group Title Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants) Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants)
    Arm/Group Description Amendment (f) Low Risk Participants: Participants received 175 mg BEB administered IV. Amendment (f) Low Risk Participants: Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV. Amendment (f) Low Risk Participants: Participants received placebo administered IV.
    Measure Participants 113 115 113
    Least Squares Mean (Standard Error) [unitless]
    -3.77
    (0.198)
    -4.00
    (0.196)
    -3.62
    (0.198)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 3: 700 mg BAM +1400 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.606
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSM Difference
    Estimated Value -0.14
    Confidence Interval (2-Sided) 95%
    -0.70 to 0.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Treatment 2: 175 mg BAM +350 mg ETE, Treatment 3: 700 mg BAM +1400 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.170
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSM Difference
    Estimated Value -0.38
    Confidence Interval (2-Sided) 95%
    -0.93 to 0.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    17. Secondary Outcome
    Title Treatment 12 -13 Amendment (f), High Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
    Description Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.
    Time Frame Baseline, Day 7

    Outcome Measure Data

    Analysis Population Description
    Treatment 12 -13 Amendment (f), High Risk Participants: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
    Arm/Group Title Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants) Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants)
    Arm/Group Description Amendment (f) High Risk Participants: Participants received 175 mg BEB administered IV. Amendment (f) High Risk Participants: Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV.
    Measure Participants 88 47
    Mean (Standard Deviation) [unitless]
    -3.22
    (2.585)
    -3.43
    (2.835)
    18. Secondary Outcome
    Title Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
    Description Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.
    Time Frame Baseline, Day 7

    Outcome Measure Data

    Analysis Population Description
    Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
    Arm/Group Title Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB(Amendment (g), High Risk,Updated CDC Criteria)
    Arm/Group Description Amendment (g), High Risk, Updated CDC Criteria): Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV for participants in updated CDC criteria.
    Measure Participants 157
    Mean (Standard Error) [unitless]
    -4.00
    (2.514)
    19. Secondary Outcome
    Title Addendum 4, IV: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
    Description Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.
    Time Frame Baseline, Day 7

    Outcome Measure Data

    Analysis Population Description
    Addendum 4, IV: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
    Arm/Group Title Pooled Placebo (Addendum 4, IV) 70 mg BEB 140 mg/Min (Addendum 4, IV) 175 BEB 140 mg/Min (Addendum 4, IV) 175 BEB 350 mg/Min (Addendum 4, IV) 175/700/1400 BAM+ETE+BEB 350mg/Min (Addendum 4, IV) 1750 BEB 350 mg/Min (Addendum 4, IV)
    Arm/Group Description Participants received placebo administered IV. Participants received 70 mg BEB 140 mg/min IV. Participants received 175 mg BEB 140 mg/min IV. Participants received 175 mg BEB 350 mg/min IV. Participants received 175 mg BAM + 700 mg ETE + 1400 mg BEB 350 mg/min IV. Participants received 1750 mg BEB 350 mg/min IV.
    Measure Participants 8 6 5 6 5 5
    Mean (Standard Deviation) [unitless]
    -4.27
    (3.087)
    -4.39
    (2.334)
    -4.40
    (3.188)
    -4.49
    (1.925)
    -6.35
    (1.502)
    -4.76
    (2.217)
    20. Secondary Outcome
    Title Addendum 4, SC: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
    Description Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.
    Time Frame Baseline, Day 7

    Outcome Measure Data

    Analysis Population Description
    Addendum 4, SC: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
    Arm/Group Title Pooled Placebo (Addendum 4, SC) 280 mg BEB (Addendum 4, SC) 560 mg BEB (Addendum 4, SC
    Arm/Group Description Participants received Placebo SC. Participants received 280 mg BEB SC. Participants received 560 mg BEB SC.
    Measure Participants 3 6 6
    Mean (Standard Deviation) [unitless]
    -3.47
    (3.934)
    -4.04
    (2.114)
    -3.40
    (1.900)
    21. Secondary Outcome
    Title Addendum (2): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
    Description Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.
    Time Frame Baseline, Day 7

    Outcome Measure Data

    Analysis Population Description
    Addendum (2): All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
    Arm/Group Title 700 mg BAM 15-min (Addendum (2)) 700 mg BAM + 1400 mg ETE 30-min (Addendum (2)) 700 mg BAM + 1400 mg ETE 15-min (Addendum (2))
    Arm/Group Description Participants received 700 mg BAM administered IV. Addendum 2 explored the safety of accelerated intravenous (IV) administration of BAM alone and in combination with ETE. Participants received 700 mg BAM +1400 mg ETE administered IV. Addendum 2 explored the safety of accelerated intravenous (IV) administration of BAM alone and in combination with ETE. Participants received 700 mg BAM +1400 mg ETE administered IV. Addendum 2 explored the safety of accelerated intravenous (IV) administration of BAM alone and in combination with ETE.
    Measure Participants 27 5 25
    Mean (Standard Deviation) [unitless]
    -2.65
    (2.394)
    -4.90
    (1.999)
    -4.37
    (2.128)
    22. Secondary Outcome
    Title Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Resolution
    Description Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) 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). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom resolution (yes/no) is defined as all symptoms (excluding loss of appetite, taste, and smell) on the symptom questionnaire scored as absent (score of 0). Missing data was imputed using a non-responder imputation.
    Time Frame Day 7

    Outcome Measure Data

    Analysis Population Description
    Treatment 1-6 and Unintentional Dosing Arms: All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and had non-missing Symptom Resolution values.
    Arm/Group Title Treatment 1: Pbo Treatment 2: 175 mg BAM +350 mg ETE Treatment 3: 700 mg BAM +1400 mg ETE Treatment 4: 2800 mg BAM +2800 mg ETE Treatment 5: 700 mg BAM Treatment 6: 350 mg BAM +700 mg ETE Unintentional Dosing: 700 mg Bamlanivimab +700 mg Etesevimab
    Arm/Group Description Participants received placebo (Pbo) administered intravenously (IV). Participants received 175 milligrams (mg) bamlanivimab (BAM) +350 mg etesevimab (ETE) administered IV. Participants received 700 mg BAM +1400 mg ETE administered IV. Participants received 2800 mg BAM + 2800 mg ETE administered IV. Participants received 700 mg BAM administered IV. Participants received 350 mg BAM +700 mg ETE administered IV. Participants received 700 mg bamlanivimab +700 mg etesevimab administered IV.
    Measure Participants 155 82 157 103 105 101 20
    Number (95% Confidence Interval) [percentage of participants]
    29.0
    18.7%
    28.0
    33.7%
    36.9
    23.4%
    32.0
    31.1%
    41.0
    39%
    32.7
    32.4%
    30.0
    150%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 2: 175 mg BAM +350 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.890
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.96
    Confidence Interval (2-Sided) 95%
    0.53 to 1.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 3: 700 mg BAM +1400 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.141
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.43
    Confidence Interval (2-Sided) 95%
    0.89 to 2.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 4: 2800 mg BAM +2800 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.603
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.15
    Confidence Interval (2-Sided) 95%
    0.67 to 1.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 5: 700 mg BAM
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.048
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.69
    Confidence Interval (2-Sided) 95%
    1.00 to 2.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 6: 350 mg BAM +700 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.533
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.19
    Confidence Interval (2-Sided) 95%
    0.69 to 2.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Unintentional Dosing: 700 mg BAM +700 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.869
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.09
    Confidence Interval (2-Sided) 95%
    0.40 to 2.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    23. Secondary Outcome
    Title Treatment 7-8 Amendments (C-e): Percentage of Participants Demonstrating Symptom Resolution
    Description Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) 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). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom resolution (yes/no) is defined as all symptoms (excluding loss of appetite, taste, and smell) on the symptom questionnaire scored as absent (score of 0). Missing data was imputed using a non-responder imputation.
    Time Frame Day 7

    Outcome Measure Data

    Analysis Population Description
    Treatment 7-8 Amendments (c-e): All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and had non-missing Symptom Resolution values.
    Arm/Group Title Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))
    Arm/Group Description Participants received 700 mg BAM + 500 mg VIR-7831 administered IV. Participants received placebo administered IV.
    Measure Participants 101 101
    Number (95% Confidence Interval) [percentage of participants]
    35.6
    23%
    29.7
    35.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 2: 175 mg BAM +350 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.374
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.31
    Confidence Interval (2-Sided) 95%
    0.72 to 2.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    24. Secondary Outcome
    Title Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Demonstrating Symptom Resolution
    Description Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) 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). Loss of taste and smell was scored as Yes (Y) or No (N). 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. Missing data was imputed using a non-responder imputation.
    Time Frame Day 7

    Outcome Measure Data

    Analysis Population Description
    Treatment 9-11 Amendment (f), Low Risk Participants: All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and had non-missing Symptom Resolution values.
    Arm/Group Title Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants) Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants)
    Arm/Group Description Amendment (f) Low Risk Participants: Participants received 175 mg BEB administered IV. Amendment (f) Low Risk Participants: Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV. Amendment (f) Low Risk Participants: Participants received placebo administered IV.
    Measure Participants 125 126 126
    Number (95% Confidence Interval) [percentage of participants]
    60.0
    38.7%
    50.8
    61.2%
    44.4
    28.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 3: 700 mg BAM +1400 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.015
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.87
    Confidence Interval (2-Sided) 95%
    1.13 to 3.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Treatment 2: 175 mg BAM +350 mg ETE, Treatment 3: 700 mg BAM +1400 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.317
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.29
    Confidence Interval (2-Sided) 95%
    0.78 to 2.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    25. Secondary Outcome
    Title Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Resolution
    Description Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) 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). Loss of taste and smell was scored as Yes (Y) or No (N). 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. Missing data was imputed using a non-responder imputation.
    Time Frame Day 7

    Outcome Measure Data

    Analysis Population Description
    Treatment 12 -13 Amendment (f), High Risk Participants: All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and had non-missing Symptom Resolution values.
    Arm/Group Title Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants) Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants)
    Arm/Group Description Amendment (f) High Risk Participants: Participants received 175 mg BEB administered IV. Amendment (f) High Risk Participants: Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV.
    Measure Participants 99 50
    Number (95% Confidence Interval) [percentage of participants]
    50.5
    32.6%
    52.0
    62.7%
    26. Secondary Outcome
    Title Treatment 14, Amendment (g) High Risk Participants Updated CDC Criteria Amendment (g): Percentage of Participants Demonstrating Symptom Resolution
    Description Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) 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). Loss of taste and smell was scored as Yes (Y) or No (N). 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. Missing data was imputed using a non-responder imputation.
    Time Frame Day 7

    Outcome Measure Data

    Analysis Population Description
    Treatment 14, Amendment (g) High Risk Participants Updated CDC Criteria Amendment (g): All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and had non-missing Symptom Resolution values.
    Arm/Group Title 700 mg BAM + 1400 mg ETE + 175 mg BEB (Amendment (g))
    Arm/Group Description Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV.
    Measure Participants 176
    Number (95% Confidence Interval) [percentage of participants]
    47.2
    30.5%
    27. Secondary Outcome
    Title Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Improvement
    Description Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) 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). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.
    Time Frame Day 7

    Outcome Measure Data

    Analysis Population Description
    Treatment 1-6 and Unintentional Dosing Arms: All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and had non-missing Symptom Improvement values.
    Arm/Group Title Placebo 175 mg Bamlanivimab +350 mg Etesevimab 350 mg Bamlanivimab +700 mg Etesevimab 700 mg Bamlanivimab +1400 mg Etesevimab 2800 mg Bamlanivimab +2800 mg Etesevimab 700 mg Bamlanivimab Unintentional Dosing Arm: 700 mg Bamlanivimab +700 mg Etesevimab
    Arm/Group Description Participants received placebo administered intravenously (IV). Participants received 175 milligrams (mg) bamlanivimab +350 mg etesevimab administered IV. Participants received 350 mg bamlanivimab +700 mg etesevimab administered IV. Participants received 700 mg bamlanivimab +1400 mg etesevimab administered IV. Participants received 2800 mg bamlanivimab + 2800 mg etesevimab administered IV. Participants received 700 mg bamlanivimab administered IV. Participants received 700 mg bamlanivimab +700 mg etesevimab administered IV.
    Measure Participants 155 82 101 157 103 105 20
    Number (95% Confidence Interval) [percentage of participants]
    33.5
    21.6%
    45.1
    54.3%
    48.5
    30.7%
    46.5
    45.1%
    49.5
    47.1%
    52.4
    51.9%
    40.0
    200%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 2: 175 mg BAM +350 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.082
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.62
    Confidence Interval (2-Sided) 95%
    0.94 to 2.81
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 3: 700 mg BAM +1400 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.018
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.86
    Confidence Interval (2-Sided) 95%
    1.11 to 3.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 4: 2800 mg BAM +2800 mg ETE
    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 1.71
    Confidence Interval (2-Sided) 95%
    1.09 to 2.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 5: 700 mg BAM
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.011
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.93
    Confidence Interval (2-Sided) 95%
    1.16 to 3.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 6: 350 mg BAM +700 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.003
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.17
    Confidence Interval (2-Sided) 95%
    1.30 to 3.60
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Unintentional Dosing: 700 mg BAM +700 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.546
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.34
    Confidence Interval (2-Sided) 95%
    0.52 to 3.48
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    28. Secondary Outcome
    Title Treatment 7-8 Amendments (C-E): Percentage of Participants Demonstrating Symptom Improvement
    Description Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) 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). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.
    Time Frame Day 7

    Outcome Measure Data

    Analysis Population Description
    Treatment 7-8 Amendments (C-E): All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and had non-missing Symptom Improvement values.
    Arm/Group Title Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))
    Arm/Group Description Participants received 700 mg BAM + 500 mg VIR-7831 administered IV. Participants received placebo administered IV.
    Measure Participants 101 101
    Number (95% Confidence Interval) [percentage of participants]
    43.6
    28.1%
    42.6
    51.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 2: 175 mg BAM +350 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.888
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.04
    Confidence Interval (2-Sided) 95%
    0.60 to 1.82
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    29. Secondary Outcome
    Title Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Demonstrating Symptom Improvement
    Description Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) 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). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.
    Time Frame Day 7

    Outcome Measure Data

    Analysis Population Description
    Treatment 9-11 Amendment (f), Low Risk Participants: All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and and had non-missing Symptom Improvement values.
    Arm/Group Title Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants) Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants)
    Arm/Group Description Amendment (f) Low Risk Participants: Participants received placebo administered IV. Amendment (f) Low Risk Participants: Participants received 175 mg BEB administered IV. Amendment (f) Low Risk Participants: Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV.
    Measure Participants 126 125 126
    Number (95% Confidence Interval) [percentage of participants]
    34.9
    22.5%
    50.4
    60.7%
    46.8
    29.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 2: 175 mg BAM +350 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.014
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.88
    Confidence Interval (2-Sided) 95%
    1.13 to 3.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Treatment 1: Pbo, Treatment 3: 700 mg BAM +1400 mg ETE
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.057
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.63
    Confidence Interval (2-Sided) 95%
    0.98 to 2.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    30. Secondary Outcome
    Title Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Improvement
    Description Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) 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). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.
    Time Frame Day 7

    Outcome Measure Data

    Analysis Population Description
    Treatment 12 -13 Amendment (f), High Risk Participants: All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and had non-missing Symptom Improvement values.
    Arm/Group Title Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants) Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants)
    Arm/Group Description Amendment (f) High Risk Participants: Participants received 175 mg BEB administered IV. Amendment (f) High Risk Participants: Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV.
    Measure Participants 99 50
    Number (95% Confidence Interval) [percentage of participants]
    42.4
    27.4%
    42.0
    50.6%
    31. Secondary Outcome
    Title Treatment 14 Amendment (g): Percentage of Participants Demonstrating Symptom Improvement
    Description Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) 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). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.
    Time Frame Day 7

    Outcome Measure Data

    Analysis Population Description
    Treatment 14 Amendment (g): All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and had non-missing Symptom Improvement values.
    Arm/Group Title Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB(Amendment (g), High Risk,Updated CDC Criteria)
    Arm/Group Description Amendment (g), High Risk, Updated CDC Criteria): Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV for participants in updated CDC criteria..
    Measure Participants 176
    Number (95% Confidence Interval) [percentage of participants]
    38.6
    24.9%
    32. Secondary Outcome
    Title Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
    Description Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
    Time Frame Baseline through Day 29

    Outcome Measure Data

    Analysis Population Description
    Treatment 1-6 and Unintentional Dosing Arms: All participants randomly assigned and who received any amount of study drug.
    Arm/Group Title Treatment 1: Pbo Treatment 2: 175 mg BAM +350 mg ETE Treatment 3: 700 mg BAM +1400 mg ETE Treatment 4: 2800 mg BAM +2800 mg ETE Treatment 5: 700 mg BAM Treatment 6: 350 mg BAM +700 mg ETE Unintentional Dosing: 700 mg Bamlanivimab +700 mg Etesevimab
    Arm/Group Description Participants received placebo (Pbo) administered intravenously (IV). Participants received 175 milligrams (mg) bamlanivimab (BAM) +350 mg etesevimab (ETE) administered IV. Participants received 700 mg BAM +1400 mg ETE administered IV. Participants received 2800 mg BAM + 2800 mg ETE administered IV. Participants received 700 mg BAM administered IV. Participants received 350 mg BAM +700 mg ETE administered IV. Participants received 700 mg bamlanivimab +700 mg etesevimab administered IV.
    Measure Participants 155 83 158 103 105 101 20
    Number (95% Confidence Interval) [percentage of participants]
    1.9
    1.2%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    1.0
    1%
    0.0
    0%
    5.0
    25%
    33. Secondary Outcome
    Title Treatment 7-8 Amendments (C-E): Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
    Description Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
    Time Frame Baseline through Day 29

    Outcome Measure Data

    Analysis Population Description
    Treatment 7-8 Amendment (C-E): No participants met the criteria (duration had to be 24 or more, and had to occur on Day 29 or before).
    Arm/Group Title Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))
    Arm/Group Description Participants received 700 mg BAM + 500 mg VIR-7831 administered IV. Participants received placebo administered IV.
    Measure Participants 101 101
    Number (95% Confidence Interval) [percentage of participants]
    1.0
    0.6%
    0.0
    0%
    34. Secondary Outcome
    Title Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
    Description Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
    Time Frame Baseline through Day 29

    Outcome Measure Data

    Analysis Population Description
    Treatment 9-11 Amendment (f), Low Risk Participants: All participants randomly assigned and who received any amount of study drug.
    Arm/Group Title Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants) Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants)
    Arm/Group Description Amendment (f) Low Risk Participants: Participants received 175 mg BEB administered IV. Amendment (f) Low Risk Participants: Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV.. Amendment (f) Low Risk Participants: Participants received placebo administered IV.
    Measure Participants 125 127 128
    Number (95% Confidence Interval) [percentage of participants]
    1.6
    1%
    2.4
    2.9%
    1.6
    1%
    35. Secondary Outcome
    Title Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
    Description Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
    Time Frame Baseline through Day 29

    Outcome Measure Data

    Analysis Population Description
    Treatment 12 -13 Amendment (f), High Risk Participants: All participants randomly assigned and who received any amount of study drug.
    Arm/Group Title Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants) Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants)
    Arm/Group Description Amendment (f) High Risk Participants: Participants received 175 mg BEB administered IV. Amendment (f) High Risk Participants: Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV.
    Measure Participants 100 50
    Number (95% Confidence Interval) [percentage of participants]
    6.0
    3.9%
    6.0
    7.2%
    36. Secondary Outcome
    Title Treatment 14 Amendment (g): Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
    Description Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
    Time Frame Baseline through Day 29

    Outcome Measure Data

    Analysis Population Description
    Treatment 14 Amendment (g): All participants randomly assigned and who received any amount of study drug.
    Arm/Group Title Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB(Amendment (g), High Risk,Updated CDC Criteria)
    Arm/Group Description Amendment (g), High Risk, Updated CDC Criteria): Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV for participants in updated CDC criteria.
    Measure Participants 176
    Number (95% Confidence Interval) [percentage of participants]
    2.3
    1.5%
    37. Secondary Outcome
    Title Pharmacokinetics (PK): Mean Concentration of Bamlanivimab
    Description PK: Mean Concentration of Bamlanivimab
    Time Frame Day 29

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received 700 mg BAM and had evaluable PK data.
    Arm/Group Title 700 mg BAM
    Arm/Group Description Participants received 700 mg BAM administered IV.
    Measure Participants 374
    Geometric Least Squares Mean (Geometric Coefficient of Variation) [Microgram/milliliter (µg/mL)]
    30.0
    (36.4)
    38. Secondary Outcome
    Title Pharmacokinetics (PK): Mean Concentration of Etesevimab
    Description Pharmacokinetics (PK): Mean Concentration of Etesevimab
    Time Frame Day 29

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received 1400 ETE and had evaluable PK data.
    Arm/Group Title 1400 mg ETE
    Arm/Group Description Participants received 1400 mg ETE administered IV.
    Measure Participants 319
    Geometric Least Squares Mean (Geometric Coefficient of Variation) [µg/mL]
    105
    (36.0)
    39. Secondary Outcome
    Title Pharmacokinetics (PK): Mean Concentration of Bebtelovimab
    Description Pharmacokinetics (PK): Mean Concentration of Bebtelovimab
    Time Frame Day 29

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received 175 mg BEB and had evaluable PK data.
    Arm/Group Title 175 mg BEB
    Arm/Group Description Participants received 175 mg BEB administered IV.
    Measure Participants 520
    Geometric Least Squares Mean (Geometric Coefficient of Variation) [µg/mL]
    4.18
    (80.4)
    40. Secondary Outcome
    Title Pharmacokinetics (PK): Mean Concentration of VIR-7831
    Description PK: Mean Concentration of VIR-7831
    Time Frame Day 29

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received 500 mg VIR-7831 and had evaluable PK data.
    Arm/Group Title 500 mg VIR-7831
    Arm/Group Description Participants received 500 mg VIR-7831 administered IV.
    Measure Participants 64
    Geometric Least Squares Mean (Geometric Coefficient of Variation) [µg/mL]
    46.3
    (47.4)

    Adverse Events

    Time Frame Baseline Up To 169 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 Treatment 1: Pbo Treatment 2: 175 mg BAM +350 mg ETE Treatment 3: 700 mg BAM +1400 mg ETE Treatment 4: 2800 mg BAM +2800 mg ETE Treatment 5: 700 mg BAM Treatment 6: 350 mg BAM +700 mg ETE Unintentional Dosing: 700 mg BAM +700 mg ETE Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants) Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants) Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants) Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants) Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB (Amendment (g)), High Risk,Updated CDC Criteria) 700 mg BAM 15-min (Addendum (2)) 700 mg BAM + 1400 mg ETE 30-min (Addendum (2)) 700 mg BAM + 1400 mg ETE 15-min (Addendum (2)) Pooled Placebo (Addendum 4, IV) 70 mg BEB 140 mg/Min (Addendum 4, IV) 175 mg BEB 140 mg/Min (Addendum 4, IV) 175 mg BEB 350 mg/Min (Addendum 4, IV) 175/700/1400 mg BAM + ETE + BEB 350 mg/Min (Addendum 4, IV) 1750 mg BEB 350 mg/Min (Addendum 4, IV) Pooled Placebo (Addendum 4, SC) 280 mg BEB (Addendum 4, SC) 560 mg BEB (Addendum 4, SC)
    Arm/Group Description Participants received placebo (Pbo) administered intravenously (IV). Participants received 175 milligrams (mg) bamlanivimab (BAM) +350 mg etesevimab (ETE) administered IV. Participants received 700 mg BAM +1400 mg ETE administered IV. Participants received 2800 mg BAM + 2800 mg ETE administered IV. Participants received 700 mg BAM administered IV. Participants received 350 mg BAM +700 mg ETE administered IV. Participants received 700 mg BAM +700 mg ETE administered IV. Participants received 700 mg BAM + 500 mg VIR-7831 administered IV. Participants received placebo administered IV. Amendment (f) Low Risk Participants: Participants received 175 mg BEB administered IV. Amendment (f) Low Risk Participants: Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV Amendment (f) Low Risk Participants: Participants received placebo administered IV. Amendment (f) High Risk Participants: Participants received 175 mg BEB administered IV. Amendment (f) High Risk Participants: Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV. Amendment (f) High Risk Participants updated CDC criteria: Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV. Participants received 700 mg BAM administered IV. Addendum 2 explored the safety of accelerated intravenous (IV) administration of BAM alone and in combination with ETE. Participants received 700 mg BAM +1400 mg ETE administered IV. Addendum 2 explored the safety of accelerated intravenous (IV) administration of BAM alone and in combination with ETE. Participants received 700 mg BAM +1400 mg ETE administered IV. Addendum 2 explored the safety of accelerated intravenous (IV) administration of BAM alone and in combination with ETE. Participants received placebo administered IV. Participants received 70 mg BEB 140 mg/min IV. Participants received 175 mg BEB 140 mg/min IV. Participants received 175 mg BEB 350 mg/min IV. Participants received 175 mg BAM + 700 mg ETE + 1400 mg BEB 350 mg/min IV. Participants received 1750 mg BEB 350 mg/min IV. Participants received Placebo SC. Participants received 280 mg BEB SC. Participants received 560 mg BEB SC.
    All Cause Mortality
    Treatment 1: Pbo Treatment 2: 175 mg BAM +350 mg ETE Treatment 3: 700 mg BAM +1400 mg ETE Treatment 4: 2800 mg BAM +2800 mg ETE Treatment 5: 700 mg BAM Treatment 6: 350 mg BAM +700 mg ETE Unintentional Dosing: 700 mg BAM +700 mg ETE Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants) Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants) Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants) Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants) Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB (Amendment (g)), High Risk,Updated CDC Criteria) 700 mg BAM 15-min (Addendum (2)) 700 mg BAM + 1400 mg ETE 30-min (Addendum (2)) 700 mg BAM + 1400 mg ETE 15-min (Addendum (2)) Pooled Placebo (Addendum 4, IV) 70 mg BEB 140 mg/Min (Addendum 4, IV) 175 mg BEB 140 mg/Min (Addendum 4, IV) 175 mg BEB 350 mg/Min (Addendum 4, IV) 175/700/1400 mg BAM + ETE + BEB 350 mg/Min (Addendum 4, IV) 1750 mg BEB 350 mg/Min (Addendum 4, IV) Pooled Placebo (Addendum 4, SC) 280 mg BEB (Addendum 4, SC) 560 mg BEB (Addendum 4, SC)
    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 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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/155 (0%) 0/83 (0%) 0/158 (0%) 0/103 (0%) 0/105 (0%) 0/101 (0%) 0/20 (0%) 0/101 (0%) 0/101 (0%) 0/125 (0%) 1/127 (0.8%) 0/128 (0%) 1/100 (1%) 0/50 (0%) 0/176 (0%) 0/30 (0%) 0/6 (0%) 0/30 (0%) 0/10 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%)
    Serious Adverse Events
    Treatment 1: Pbo Treatment 2: 175 mg BAM +350 mg ETE Treatment 3: 700 mg BAM +1400 mg ETE Treatment 4: 2800 mg BAM +2800 mg ETE Treatment 5: 700 mg BAM Treatment 6: 350 mg BAM +700 mg ETE Unintentional Dosing: 700 mg BAM +700 mg ETE Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants) Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants) Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants) Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants) Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB (Amendment (g)), High Risk,Updated CDC Criteria) 700 mg BAM 15-min (Addendum (2)) 700 mg BAM + 1400 mg ETE 30-min (Addendum (2)) 700 mg BAM + 1400 mg ETE 15-min (Addendum (2)) Pooled Placebo (Addendum 4, IV) 70 mg BEB 140 mg/Min (Addendum 4, IV) 175 mg BEB 140 mg/Min (Addendum 4, IV) 175 mg BEB 350 mg/Min (Addendum 4, IV) 175/700/1400 mg BAM + ETE + BEB 350 mg/Min (Addendum 4, IV) 1750 mg BEB 350 mg/Min (Addendum 4, IV) Pooled Placebo (Addendum 4, SC) 280 mg BEB (Addendum 4, SC) 560 mg BEB (Addendum 4, SC)
    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 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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/155 (0%) 0/83 (0%) 1/158 (0.6%) 0/103 (0%) 0/105 (0%) 2/101 (2%) 1/20 (5%) 0/101 (0%) 0/101 (0%) 0/125 (0%) 1/127 (0.8%) 0/128 (0%) 3/100 (3%) 2/50 (4%) 2/176 (1.1%) 0/30 (0%) 0/6 (0%) 1/30 (3.3%) 0/10 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%)
    Immune system disorders
    Hypersensitivity 0/155 (0%) 0 0/83 (0%) 0 1/158 (0.6%) 1 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Infections and infestations
    Osteomyelitis 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 1/176 (0.6%) 2 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Injury, poisoning and procedural complications
    Femur fracture 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 1/50 (2%) 1 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Infusion related reaction 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 1/101 (1%) 1 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Lower limb fracture 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 1/176 (0.6%) 1 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Meniscus injury 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 1/30 (3.3%) 1 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Road traffic accident 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 1/101 (1%) 1 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Nervous system disorders
    Cerebrovascular accident 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous 0/75 (0%) 0 0/39 (0%) 0 0/86 (0%) 0 0/55 (0%) 0 0/50 (0%) 0 0/48 (0%) 0 0/8 (0%) 0 0/52 (0%) 0 0/56 (0%) 0 0/63 (0%) 0 1/76 (1.3%) 1 0/72 (0%) 0 0/52 (0%) 0 0/26 (0%) 0 0/98 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/13 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/1 (0%) 0 0/1 (0%) 0 0/2 (0%) 0
    Psychiatric disorders
    Psychotic disorder 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 1/50 (2%) 1 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 1/20 (5%) 1 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Other (Not Including Serious) Adverse Events
    Treatment 1: Pbo Treatment 2: 175 mg BAM +350 mg ETE Treatment 3: 700 mg BAM +1400 mg ETE Treatment 4: 2800 mg BAM +2800 mg ETE Treatment 5: 700 mg BAM Treatment 6: 350 mg BAM +700 mg ETE Unintentional Dosing: 700 mg BAM +700 mg ETE Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants) Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants) Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants) Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants) Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB (Amendment (g)), High Risk,Updated CDC Criteria) 700 mg BAM 15-min (Addendum (2)) 700 mg BAM + 1400 mg ETE 30-min (Addendum (2)) 700 mg BAM + 1400 mg ETE 15-min (Addendum (2)) Pooled Placebo (Addendum 4, IV) 70 mg BEB 140 mg/Min (Addendum 4, IV) 175 mg BEB 140 mg/Min (Addendum 4, IV) 175 mg BEB 350 mg/Min (Addendum 4, IV) 175/700/1400 mg BAM + ETE + BEB 350 mg/Min (Addendum 4, IV) 1750 mg BEB 350 mg/Min (Addendum 4, IV) Pooled Placebo (Addendum 4, SC) 280 mg BEB (Addendum 4, SC) 560 mg BEB (Addendum 4, SC)
    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 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 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 16/155 (10.3%) 14/83 (16.9%) 13/158 (8.2%) 9/103 (8.7%) 12/105 (11.4%) 7/101 (6.9%) 4/20 (20%) 6/101 (5.9%) 10/101 (9.9%) 11/125 (8.8%) 15/127 (11.8%) 10/128 (7.8%) 19/100 (19%) 7/50 (14%) 20/176 (11.4%) 3/30 (10%) 0/6 (0%) 2/30 (6.7%) 1/10 (10%) 0/6 (0%) 2/6 (33.3%) 0/6 (0%) 1/6 (16.7%) 1/6 (16.7%) 1/4 (25%) 2/6 (33.3%) 1/6 (16.7%)
    Blood and lymphatic system disorders
    Anaemia 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 1/176 (0.6%) 1 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Leukopenia 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 1/125 (0.8%) 1 1/127 (0.8%) 1 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Lymphadenopathy 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Neutropenia 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 1/125 (0.8%) 1 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Thrombocytosis 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 1/101 (1%) 1 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Cardiac disorders
    Atrial fibrillation 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 2/176 (1.1%) 2 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Diastolic dysfunction 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Palpitations 0/155 (0%) 0 1/83 (1.2%) 1 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Tachycardia 0/155 (0%) 0 1/83 (1.2%) 1 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 1/101 (1%) 1 1/20 (5%) 1 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Ear and labyrinth disorders
    Ear pain 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 1/127 (0.8%) 1 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Eustachian tube dysfunction 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 1/125 (0.8%) 1 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Tinnitus 1/155 (0.6%) 1 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Eye disorders
    Eye haemorrhage 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Gastrointestinal disorders
    Constipation 1/155 (0.6%) 1 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Diarrhoea 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 1/127 (0.8%) 1 1/128 (0.8%) 1 0/100 (0%) 0 1/50 (2%) 1 1/176 (0.6%) 1 1/30 (3.3%) 1 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Dyspepsia 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 1/127 (0.8%) 1 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Gastrooesophageal reflux disease 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 1/127 (0.8%) 1 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Gingival bleeding 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 1/128 (0.8%) 2 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Gingival discomfort 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 1/128 (0.8%) 1 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Lip blister 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Mouth ulceration 0/155 (0%) 0 1/83 (1.2%) 1 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Nausea 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 1/103 (1%) 1 0/105 (0%) 0 0/101 (0%) 0 1/20 (5%) 1 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 2/127 (1.6%) 2 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 2/176 (1.1%) 2 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Toothache 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 1/101 (1%) 1 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Vomiting 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 1/103 (1%) 1 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 2/125 (1.6%) 2 1/127 (0.8%) 1 1/128 (0.8%) 1 0/100 (0%) 0 0/50 (0%) 0 1/176 (0.6%) 1 1/30 (3.3%) 1 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    General disorders
    Chest discomfort 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 2/103 (1.9%) 2 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 1/127 (0.8%) 1 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 1/176 (0.6%) 1 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Chest pain 1/155 (0.6%) 1 2/83 (2.4%) 2 0/158 (0%) 0 1/103 (1%) 1 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Fatigue 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 1/127 (0.8%) 1 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Infusion site extravasation 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Infusion site pruritus 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 1/127 (0.8%) 1 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Injection site pain 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 1/30 (3.3%) 1 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Non-cardiac chest pain 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Pyrexia 0/155 (0%) 0 1/83 (1.2%) 1 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Hepatobiliary disorders
    Biliary colic 0/155 (0%) 0 0/83 (0%) 0 1/158 (0.6%) 1 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Cholelithiasis 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 1/101 (1%) 1 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Immune system disorders
    Drug hypersensitivity 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 1/176 (0.6%) 1 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Infections and infestations
    Bronchitis 0/155 (0%) 0 1/83 (1.2%) 1 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Covid-19 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 1/176 (0.6%) 1 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Cystitis 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Gastroenteritis 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 1/101 (1%) 1 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Hordeolum 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 1/103 (1%) 1 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Influenza 1/155 (0.6%) 1 0/83 (0%) 0 1/158 (0.6%) 1 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 1/176 (0.6%) 1 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Nasopharyngitis 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 1/101 (1%) 1 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Oral candidiasis 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 1/127 (0.8%) 1 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 1/30 (3.3%) 1 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Osteomyelitis 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 1/176 (0.6%) 1 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Otitis media 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 1/176 (0.6%) 1 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Otitis media acute 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Pelvic inflammatory disease 0/75 (0%) 0 0/39 (0%) 0 0/86 (0%) 0 0/55 (0%) 0 0/50 (0%) 0 0/48 (0%) 0 0/8 (0%) 0 0/52 (0%) 0 0/56 (0%) 0 0/63 (0%) 0 0/76 (0%) 0 1/72 (1.4%) 1 0/52 (0%) 0 0/26 (0%) 0 0/98 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/13 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/1 (0%) 0 0/1 (0%) 0 0/2 (0%) 0
    Pharyngitis 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 1/127 (0.8%) 1 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Pharyngitis streptococcal 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 2/125 (1.6%) 2 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Pneumonia 2/155 (1.3%) 2 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Pneumonia bacterial 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 1/128 (0.8%) 1 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Sinusitis 0/155 (0%) 0 2/83 (2.4%) 2 2/158 (1.3%) 2 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Tonsillitis 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 1/125 (0.8%) 1 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Upper respiratory tract infection 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 1/125 (0.8%) 1 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Urinary tract infection 0/155 (0%) 0 0/83 (0%) 0 1/158 (0.6%) 1 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 1/127 (0.8%) 1 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 1/176 (0.6%) 1 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Injury, poisoning and procedural complications
    Concussion 0/155 (0%) 0 1/83 (1.2%) 1 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Contusion 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 1/128 (0.8%) 1 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 1/10 (10%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Femur fracture 1/155 (0.6%) 1 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Hand fracture 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 1/128 (0.8%) 1 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Infusion related reaction 0/155 (0%) 0 0/83 (0%) 0 1/158 (0.6%) 1 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 1/50 (2%) 1 1/176 (0.6%) 1 0/30 (0%) 0 0/6 (0%) 0 1/30 (3.3%) 1 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Joint dislocation 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 1/103 (1%) 1 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Ligament sprain 0/155 (0%) 0 1/83 (1.2%) 1 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 1/101 (1%) 1 0/20 (0%) 0 0/101 (0%) 0 1/101 (1%) 1 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Procedural pain 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 1/30 (3.3%) 1 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Product administration interrupted 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 1/176 (0.6%) 1 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Road traffic accident 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 1/105 (1%) 1 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Skin laceration 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 1/101 (1%) 2 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Stress fracture 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 1/101 (1%) 1 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Investigations
    Activated partial thromboplastin time prolonged 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 1/50 (2%) 1 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Alanine aminotransferase increased 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 1/127 (0.8%) 1 0/128 (0%) 0 0/100 (0%) 0 1/50 (2%) 1 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Amylase increased 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 1/127 (0.8%) 1 1/128 (0.8%) 1 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Aspartate aminotransferase increased 1/155 (0.6%) 1 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 1/127 (0.8%) 1 0/128 (0%) 0 0/100 (0%) 0 1/50 (2%) 1 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Blood alkaline phosphatase increased 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 1/176 (0.6%) 1 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Blood cholesterol increased 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 1/50 (2%) 1 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Blood creatine phosphokinase increased 1/155 (0.6%) 1 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 1/127 (0.8%) 1 0/128 (0%) 0 2/100 (2%) 2 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Blood lactate dehydrogenase increased 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 1/50 (2%) 1 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Blood magnesium decreased 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Blood oestrogen decreased 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Blood phosphorus decreased 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 2/100 (2%) 2 0/50 (0%) 0 1/176 (0.6%) 1 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Blood pressure increased 1/155 (0.6%) 1 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    C-reactive protein increased 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 1/50 (2%) 1 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Fibrin d dimer increased 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Haematocrit decreased 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Haemoglobin decreased 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Hepatic enzyme increased 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 1/20 (5%) 1 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Lipase increased 0/155 (0%) 0 0/83 (0%) 0 1/158 (0.6%) 1 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 1/128 (0.8%) 1 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Liver function test abnormal 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Liver function test increased 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 1/176 (0.6%) 1 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Platelet count increased 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Red blood cell count decreased 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Serum ferritin increased 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 1/50 (2%) 1 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Metabolism and nutrition disorders
    Diabetes mellitus 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 1/176 (0.6%) 1 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Hyperglycaemia 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Hyperlipidaemia 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 1/105 (1%) 1 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 1/101 (1%) 1 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Back pain 0/155 (0%) 0 0/83 (0%) 0 1/158 (0.6%) 1 0/103 (0%) 0 1/105 (1%) 1 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 1/101 (1%) 1 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Joint effusion 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 1/103 (1%) 1 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Myositis 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Neck pain 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Pain in extremity 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 1/105 (1%) 1 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Patellofemoral pain syndrome 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 1/125 (0.8%) 1 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung neoplasm malignant 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Nervous system disorders
    Amnesia 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 1/101 (1%) 1 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Burning sensation 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 1/103 (1%) 1 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Dizziness 2/155 (1.3%) 2 1/83 (1.2%) 1 1/158 (0.6%) 2 1/103 (1%) 1 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Headache 0/155 (0%) 0 0/83 (0%) 0 1/158 (0.6%) 1 1/103 (1%) 1 1/105 (1%) 1 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 1/125 (0.8%) 1 1/127 (0.8%) 1 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 1/176 (0.6%) 1 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Hyperaesthesia 2/155 (1.3%) 2 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 1/105 (1%) 1 1/101 (1%) 1 1/20 (5%) 1 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Hypoaesthesia 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 1/103 (1%) 1 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Paraesthesia 2/155 (1.3%) 2 0/83 (0%) 0 1/158 (0.6%) 1 1/103 (1%) 1 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 1/101 (1%) 1 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 1/10 (10%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Presyncope 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 1/125 (0.8%) 1 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 1/176 (0.6%) 1 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Sciatica 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 1/125 (0.8%) 1 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Syncope 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 1/105 (1%) 1 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 1/127 (0.8%) 1 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Tremor 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 1/176 (0.6%) 1 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Product Issues
    Device occlusion 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 1/128 (0.8%) 2 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Psychiatric disorders
    Anxiety 0/155 (0%) 0 1/83 (1.2%) 1 1/158 (0.6%) 1 0/103 (0%) 0 1/105 (1%) 1 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 2/101 (2%) 2 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 1/176 (0.6%) 1 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Bipolar disorder 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 1/101 (1%) 1 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Depression 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 1/101 (1%) 1 0/20 (0%) 0 0/101 (0%) 0 1/101 (1%) 1 1/125 (0.8%) 1 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Panic attack 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 1/103 (1%) 1 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 1/101 (1%) 2 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Post-traumatic stress disorder 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 1/101 (1%) 1 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Sleep disorder 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 1/101 (1%) 1 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Renal and urinary disorders
    Dysuria 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 1/101 (1%) 1 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Micturition urgency 0/155 (0%) 0 1/83 (1.2%) 1 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Reproductive system and breast disorders
    Bartholin's cyst 0/75 (0%) 0 0/39 (0%) 0 0/86 (0%) 0 0/55 (0%) 0 0/50 (0%) 0 1/48 (2.1%) 1 0/8 (0%) 0 0/52 (0%) 0 0/56 (0%) 0 0/63 (0%) 0 0/76 (0%) 0 0/72 (0%) 0 0/52 (0%) 0 0/26 (0%) 0 0/98 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/13 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/1 (0%) 0 0/1 (0%) 0 0/2 (0%) 0
    Breast calcifications 0/155 (0%) 0 1/83 (1.2%) 1 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Erectile dysfunction 0/80 (0%) 0 0/44 (0%) 0 0/72 (0%) 0 0/48 (0%) 0 0/55 (0%) 0 0/53 (0%) 0 0/12 (0%) 0 1/49 (2%) 1 0/45 (0%) 0 0/62 (0%) 0 0/51 (0%) 0 0/56 (0%) 0 0/48 (0%) 0 0/24 (0%) 0 0/78 (0%) 0 0/18 (0%) 0 0/6 (0%) 0 0/17 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/1 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Heavy menstrual bleeding 0/75 (0%) 0 0/39 (0%) 0 0/86 (0%) 0 0/55 (0%) 0 1/50 (2%) 1 0/48 (0%) 0 0/8 (0%) 0 0/52 (0%) 0 0/56 (0%) 0 0/63 (0%) 0 0/76 (0%) 0 0/72 (0%) 0 0/52 (0%) 0 0/26 (0%) 0 0/98 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/13 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/1 (0%) 0 0/1 (0%) 0 0/2 (0%) 0
    Intermenstrual bleeding 0/75 (0%) 0 0/39 (0%) 0 0/86 (0%) 0 0/55 (0%) 0 0/50 (0%) 0 0/48 (0%) 0 0/8 (0%) 0 0/52 (0%) 0 0/56 (0%) 0 1/63 (1.6%) 1 0/76 (0%) 0 0/72 (0%) 0 0/52 (0%) 0 0/26 (0%) 0 0/98 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/13 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/1 (0%) 0 0/1 (0%) 0 0/2 (0%) 0
    Ovarian cyst ruptured 0/75 (0%) 0 0/39 (0%) 0 0/86 (0%) 0 0/55 (0%) 0 1/50 (2%) 1 0/48 (0%) 0 0/8 (0%) 0 0/52 (0%) 0 0/56 (0%) 0 0/63 (0%) 0 0/76 (0%) 0 0/72 (0%) 0 0/52 (0%) 0 0/26 (0%) 0 0/98 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/13 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/1 (0%) 0 0/1 (0%) 0 0/2 (0%) 0
    Spontaneous penile erection 0/80 (0%) 0 0/44 (0%) 0 0/72 (0%) 0 0/48 (0%) 0 0/55 (0%) 0 0/53 (0%) 0 0/12 (0%) 0 0/49 (0%) 0 0/45 (0%) 0 1/62 (1.6%) 1 0/51 (0%) 0 0/56 (0%) 0 0/48 (0%) 0 0/24 (0%) 0 0/78 (0%) 0 0/18 (0%) 0 0/6 (0%) 0 0/17 (0%) 0 0/7 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/1 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/4 (0%) 0
    Uterine haemorrhage 0/75 (0%) 0 0/39 (0%) 0 0/86 (0%) 0 0/55 (0%) 0 0/50 (0%) 0 1/48 (2.1%) 1 0/8 (0%) 0 0/52 (0%) 0 0/56 (0%) 0 0/63 (0%) 0 0/76 (0%) 0 0/72 (0%) 0 0/52 (0%) 0 0/26 (0%) 0 0/98 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/13 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/1 (0%) 0 0/1 (0%) 0 0/2 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Cough 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 1/103 (1%) 1 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Haemoptysis 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 1/101 (1%) 1 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Nasal congestion 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 1/127 (0.8%) 1 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Nasal discomfort 0/155 (0%) 0 1/83 (1.2%) 1 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/4 (25%) 1 0/6 (0%) 0 0/6 (0%) 0
    Pulmonary mass 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Sinus congestion 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 1/105 (1%) 1 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Skin and subcutaneous tissue disorders
    Acne 0/155 (0%) 0 1/83 (1.2%) 1 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Alopecia 1/155 (0.6%) 1 1/83 (1.2%) 1 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Blister 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 1/176 (0.6%) 1 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Dermatitis contact 1/155 (0.6%) 1 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 1/101 (1%) 1 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Eczema 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 1/101 (1%) 1 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Petechiae 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 1/50 (2%) 1 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Photosensitivity reaction 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 1/101 (1%) 1 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Piloerection 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Pruritus 0/155 (0%) 0 1/83 (1.2%) 1 1/158 (0.6%) 1 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 1/125 (0.8%) 1 1/127 (0.8%) 1 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Rash 0/155 (0%) 0 0/83 (0%) 0 2/158 (1.3%) 2 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 1/101 (1%) 1 0/125 (0%) 0 1/127 (0.8%) 1 1/128 (0.8%) 1 0/100 (0%) 0 1/50 (2%) 1 2/176 (1.1%) 3 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Rash erythematous 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Urticaria 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 1/103 (1%) 1 2/105 (1.9%) 3 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 1/30 (3.3%) 1 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Vascular disorders
    Deep vein thrombosis 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 1/20 (5%) 1 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Essential hypertension 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 1/101 (1%) 1 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Hypertension 0/155 (0%) 0 2/83 (2.4%) 2 1/158 (0.6%) 1 0/103 (0%) 0 1/105 (1%) 1 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 1/125 (0.8%) 1 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Hypotension 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 1/101 (1%) 1 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 0/100 (0%) 0 1/50 (2%) 1 1/176 (0.6%) 1 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Venous occlusion 0/155 (0%) 0 0/83 (0%) 0 0/158 (0%) 0 0/103 (0%) 0 0/105 (0%) 0 0/101 (0%) 0 0/20 (0%) 0 0/101 (0%) 0 0/101 (0%) 0 0/125 (0%) 0 0/127 (0%) 0 0/128 (0%) 0 1/100 (1%) 1 0/50 (0%) 0 0/176 (0%) 0 0/30 (0%) 0 0/6 (0%) 0 0/30 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0 0/6 (0%) 0 0/6 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

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

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email ClinicalTrials.gov@lilly.com
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT04634409
    Other Study ID Numbers:
    • 18160
    • J2X-MC-PYAH
    First Posted:
    Nov 18, 2020
    Last Update Posted:
    Jul 1, 2022
    Last Verified:
    Jun 1, 2022