BLAZE-4: A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness
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
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:
Drug: Etesevimab
Administered IV.
Other Names:
|
Experimental: BAM Treatment 5: 700 mg BAM administered IV. 700 mg BAM 15-min (Addendum (2)) administered IV. |
Drug: Bamlanivimab
Administered IV.
Other Names:
|
Experimental: BAM + VIR-7831 Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) administered IV. |
Drug: Bamlanivimab
Administered IV.
Other Names:
Drug: VIR-7831
Administered IV.
Other Names:
|
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:
|
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:
Drug: Etesevimab
Administered IV.
Other Names:
Drug: Bebtelovimab
Administered IV.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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).
- 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
- 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).
- 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).
- 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.
- 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).
- 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).
- 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
- 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
- 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
- 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
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- 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
- 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
- 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
- Pharmacokinetics (PK): Mean Concentration of Bamlanivimab [Day 29]
PK: Mean Concentration of Bamlanivimab
- Pharmacokinetics (PK): Mean Concentration of Etesevimab [Day 29]
Pharmacokinetics (PK): Mean Concentration of Etesevimab
- Pharmacokinetics (PK): Mean Concentration of Bebtelovimab [Day 29]
Pharmacokinetics (PK): Mean Concentration of Bebtelovimab
- Pharmacokinetics (PK): Mean Concentration of VIR-7831 [Day 29]
PK: Mean Concentration of VIR-7831
Eligibility Criteria
Criteria
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.- 18160
- J2X-MC-PYAH
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
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 |
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 |
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 |
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%
|
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%
|
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%
|
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%
|
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%
|
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 |
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 |
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 |
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%
|
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%
|
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 |
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 |
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 |
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)
|
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)
|
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)
|
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)
|
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)
|
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 |
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 |
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 |
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%
|
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%
|
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 |
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 |
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 |
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%
|
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%
|
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%
|
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%
|
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%
|
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%
|
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%
|
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)
|
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)
|
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)
|
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 |
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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 |
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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 |
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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
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 |
ClinicalTrials.gov@lilly.com |
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- J2X-MC-PYAH