Infections, Bacterial
Conditions
Keywords
Anthrax Vaccine Adsorbed, Raxibacumab, Immunogenicity
Brief summary
This study, as a post-marketing commitment to the Food and Drug Administration, is designed to detect the effect of raxibacumab on anthrax vaccine adsorbed (AVA) immunogenicity in a healthy volunteer population. This is a randomized, open-label, parallel group, two arm study to compare the immunogenicity of AVA at 4 weeks after the first AVA dose, when AVA is administered alone or concomitantly with raxibacumab. The study is planned to enroll approximately 30 to 534 subjects in up to 3 cohorts. The total duration of the study will be approximately 26 weeks. The dates reflect cohort 1.
Interventions
BIOLOGICALAVA
Sterile, milky-white suspension with dosage level of 0.5 mL for SC administration
BIOLOGICALRaxibacumab
Sterile, liquid formulation with unit dose strength of 40 mg/ kg for IV administration
DRUGDiphenhydramine
Depending upon the labelling of the specific product chosen, 25 - 50 mg will be administered orally or IV
Sponsors
GlaxoSmithKline
Emergent BioSolutions
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, physical examination and laboratory tests * Men and women between 18 to 65 years of age * Willing and able to adhere to the procedures stated in the protocol. * Female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum or urine human chorionic gonadotrophin (hCG) test), not lactating, and at least one of the following conditions applies: Non-reproductive potential defined as: Pre-menopausal females with one of the following: Documented tubal ligation, Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, Hysterectomy, Documented Bilateral Oophorectomy Postmenopausal defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. Reproductive potential and agrees to follow one of the options listed in the GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP), from 30 days prior to the first dose of study medication and until after the last dose of study medication and completion of the follow-up visit at Day 183 (at least five terminal half-lives for raxibacumab).
Exclusion criteria
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or non-investigational study vaccine/product (pharmaceutical product or device). * Be a member of the military, a laboratory worker, first responder, health care worker, or otherwise be at higher risk of exposure to anthrax. * History of regular alcohol consumption within 1 month of the study defined as: An average weekly intake of \>14 drinks for males or \>7 drinks for females. One drink is equivalent to 12 g of alcohol: 12 ounces (360 milliliter \[mL\]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits. * Female planning to become pregnant or planning to discontinue contraceptive precautions before the Day 183 study visit. * Pregnant (confirmed by a serum or urine hCG test) or lactating female. * Alanine aminotransferase (ALT) and bilirubin \>1.5 x upper limit of normal (ULN) (isolated bilirubin \>1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, human immunodeficiency virus \[HIV\] infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders). * Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test results at screening or within 3 months prior to first dose of study treatment. * A positive pre-study drug/alcohol screen. * A positive test for HIV antibody. * History of sensitivity to any of the study medications, or components thereof (especially latex and aluminium) or a history of other known drug allergies that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates their participation. * Have previously been vaccinated against PA. * Have an anti-PA Ab concentration \>2 times the lower limit of quantitation at screening. * Administration of immunoglobulins not included in this trial and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period. * Administration of long-acting immune-modifying drugs (e.g. infliximab) within six months prior to the first vaccine dose or expected administration at any time during the study period. * Chronic administration (defined as more than 14 consecutive days) of systemic immunosupressants or other immune-modifying drugs within six months prior to the first vaccine dose. Inhaled, topical and intra-articular corticosteroids are allowed. * Administration or planned administration of a vaccine not foreseen by the study protocol within the period starting 35 days before the first dose of study vaccine(s) and ending 30 days after the last dose of study vaccine. This includes any type of vaccine such as (but not limited to) live, inactivated, and subunit vaccines. Influenza vaccines are permitted after Week 8. * Subjects must abstain from taking prescription or non-prescription drugs (including vitamins and dietary or herbal supplements), within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication until completion of the follow-up visit, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study. * Exposure to more than four new chemical entities within 12 months prior to the first dosing day. * Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of Geometric Mean Concentrations (GMC) of Anti-protective Antigen (PA) Antibody (Ab) at 4 Weeks (Day 29) After the First AVA Dose (Prior to the Third AVA Dose), Between the AVA Alone and the AVA With Raxibacumab Treatment Groups | Day 29 | Ratio of the GMC of anti-PA Ab between AVA alone and the AVA with raxibacumab treatment group was assessed to compare the immunogenicity of AVA at 4 weeks after the first AVA dose (prior to the third AVA dose). Serum AVA derived anti-PA Ab concentrations were determined using an approved immunoassay. Per Protocol (PP) population was used in analysis which comprised of all analyzable participants (those who received at least the Week 0 \[Day 1\] and Week 2 \[Day 15\] AVA doses within the protocol specified visit window; receive the raxibacumab dose, if randomized to Treatment Group 2 and; completed the primary study endpoint assessment \[anti-PA Ab concentration at Week 4\]). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Seroconvert, at Weeks 4, 8, and 26 (Days 29, 57 and 183) After the First AVA Dose, Between the AVA Alone and the AVA With Raxibacumab Treatment Groups | Days 29, 57 and 183 | The percentage of participants, with corresponding 95% CI based on Wilson's method, who seroconvert (seroconversion is defined as a \>4-fold increase in toxin neutralizing activity \[TNA\] titer) was summarized, at Weeks 4, 8 and 26 after the first AVA dose for both arms separately. Serum TNA titer was determined using a cell-based assay. |
| Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (AE) | Up to Day 183 | An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE resulting in death, is life threatening (ie, an immediate threat to life), inpatient hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or any other situation which is medically important and may jeopardize the participant or may require medical or surgical intervention or events associated with liver injury and impaired liver function is categorized as SAE. The Safety population was comprised of all randomized participants who received at least one dose of AVA. |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | Baseline and up to Day 183 | SBP and DBP were measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Change From Baseline in Heart Rate at Indicated Time Points | Baseline and up to Day 183 | Heart rate was measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Ratio of GMC of Anti-PA Ab at Weeks 8 and 26 (Days 57 and 183) After the First AVA Dose, Between the AVA Alone and AVA With Raxibacumab Treatment Groups | Days 57 and 183 | Anti-PA antibody concentrations were collected at Weeks 8 and 26 after the first AVA dose. Serum AVA derived anti-PA Ab concentrations were determined using an approved immunoassay. The GMCs with corresponding 95% CI were calculated for each treatment group at each timepoint. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Change From Baseline in Temperature at Indicated Time Points | Baseline and up to Day 183 | Temperature was measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Number of Participants With Hematology Parameters Outside Normal Range | Up to Day 57 | Hematology parameters included assessment of platelet count, erythrocytes, leukocytes , reticulocyte count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils, basophils, hemoglobin and hematocrit. Here high is equal to above the upper limit of the normal range, low is equal to below the lower limit of the normal range. Participants are counted in the category that their value changes to (low, normal or high), unless there is no change in their category. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Up to Day 57 | Blood samples were collected to evaluate clinical chemistry parameters, which included assessment of urea nitrogen (UN), creatinine, chloride, glucose, magnesium, total protein, potassium, chloride, total Carbon dioxide (CO2), sodium, calcium (cal), alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltransferase (GGT), total and direct bilirubin ( D.bili), albumin and calculated creatinine clearance. Here high is equal to above the upper limit of the normal range, low is equal to below the lower limit of the normal range. Participants are counted in the category that their value changes to (low, normal or high), unless there is no change in their category. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Number of Participants With Urinalysis Parameters | Day 57 | Urinalysis parameters included amorphous crystals, bacteria, bilirubin, calcium oxalate (Ca Ox) crystals, choriogonadotropin beta, clarity, color, crystals of Ca Ox, erythrocytes, glucose, hemoglobin, ketone bodies, ketones, leukocyte cell clumps, leukocyte esterase, leukocytes, mucous threads, nitrite, occult blood, protein, specific gravity, squamous epithelial cells, turbidity, urobilinogen, and transitional epithelial cells. In urinalysis test plus sign (+) indicates increase in the level of the parameters. |
| Change From Baseline in Respiratory Rate at Indicated Time Points | Baseline and up to Day 183 | Respiratory rate was measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
Countries
United States
Participant flow
Recruitment details
This study included healthy volunteers who were not previously immunized against protective antigen. 573 participants were randomized with 566 receiving study treatment and 537 completed the study.
Pre-assignment details
A total of 573 participants were randomized with 566 receiving study treatment and 537 completed the study.
Participants by arm
| Arm | Count |
|---|---|
| AVA Alone Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29 | 287 |
| AVA+Raxibacumab Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions. | 286 |
| Total | 573 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 6 |
| Overall Study | Death | 1 | 1 |
| Overall Study | Lost to Follow-up | 8 | 9 |
| Overall Study | Physician Decision | 2 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | AVA Alone | AVA+Raxibacumab | Total |
|---|---|---|---|
| Age, Continuous | 36.2 Years STANDARD_DEVIATION 12.78 | 36.1 Years STANDARD_DEVIATION 12.06 | 36.2 Years STANDARD_DEVIATION 12.42 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 7 Participants | 1 Participants | 8 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 5 Participants | 7 Participants |
| Race/Ethnicity, Customized Black or African American | 61 Participants | 56 Participants | 117 Participants |
| Race/Ethnicity, Customized Multiple | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 216 Participants | 221 Participants | 437 Participants |
| Sex: Female, Male Female | 150 Participants | 142 Participants | 292 Participants |
| Sex: Female, Male Male | 137 Participants | 144 Participants | 281 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 286 | 0 / 6 | 1 / 280 |
| other Total, other adverse events | 85 / 286 | 6 / 6 | 80 / 280 |
| serious Total, serious adverse events | 5 / 286 | 0 / 6 | 3 / 280 |
Outcome results
Primary
Ratio of Geometric Mean Concentrations (GMC) of Anti-protective Antigen (PA) Antibody (Ab) at 4 Weeks (Day 29) After the First AVA Dose (Prior to the Third AVA Dose), Between the AVA Alone and the AVA With Raxibacumab Treatment Groups
Ratio of the GMC of anti-PA Ab between AVA alone and the AVA with raxibacumab treatment group was assessed to compare the immunogenicity of AVA at 4 weeks after the first AVA dose (prior to the third AVA dose). Serum AVA derived anti-PA Ab concentrations were determined using an approved immunoassay. Per Protocol (PP) population was used in analysis which comprised of all analyzable participants (those who received at least the Week 0 \[Day 1\] and Week 2 \[Day 15\] AVA doses within the protocol specified visit window; receive the raxibacumab dose, if randomized to Treatment Group 2 and; completed the primary study endpoint assessment \[anti-PA Ab concentration at Week 4\]).
Time frame: Day 29
Population: PP Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AVA Alone | Ratio of Geometric Mean Concentrations (GMC) of Anti-protective Antigen (PA) Antibody (Ab) at 4 Weeks (Day 29) After the First AVA Dose (Prior to the Third AVA Dose), Between the AVA Alone and the AVA With Raxibacumab Treatment Groups | 26.516 Microgram/milliliter (µg/mL) |
| AVA+Raxibacumab | Ratio of Geometric Mean Concentrations (GMC) of Anti-protective Antigen (PA) Antibody (Ab) at 4 Weeks (Day 29) After the First AVA Dose (Prior to the Third AVA Dose), Between the AVA Alone and the AVA With Raxibacumab Treatment Groups | 22.477 Microgram/milliliter (µg/mL) |
p-value: 0.001690% CI: [1.03, 1.35]t-test, 1 sided
Secondary
Change From Baseline in Heart Rate at Indicated Time Points
Heart rate was measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Baseline and up to Day 183
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AVA Alone | Change From Baseline in Heart Rate at Indicated Time Points | Day 1, n=286, 280 | -0.3 Beats per minute (bpm) | Standard Deviation 10.4 |
| AVA Alone | Change From Baseline in Heart Rate at Indicated Time Points | Day 29, n=283, 279 | -0.4 Beats per minute (bpm) | Standard Deviation 10.5 |
| AVA Alone | Change From Baseline in Heart Rate at Indicated Time Points | Day 57, n=282, 275 | -1.2 Beats per minute (bpm) | Standard Deviation 10.6 |
| AVA Alone | Change From Baseline in Heart Rate at Indicated Time Points | Day 183, n=273, 266 | 0.9 Beats per minute (bpm) | Standard Deviation 11.7 |
| AVA+Raxibacumab | Change From Baseline in Heart Rate at Indicated Time Points | Day 183, n=273, 266 | 0.7 Beats per minute (bpm) | Standard Deviation 11.5 |
| AVA+Raxibacumab | Change From Baseline in Heart Rate at Indicated Time Points | Day 1, n=286, 280 | -0.8 Beats per minute (bpm) | Standard Deviation 10.5 |
| AVA+Raxibacumab | Change From Baseline in Heart Rate at Indicated Time Points | Day 57, n=282, 275 | -0.9 Beats per minute (bpm) | Standard Deviation 11.2 |
| AVA+Raxibacumab | Change From Baseline in Heart Rate at Indicated Time Points | Day 29, n=283, 279 | -0.4 Beats per minute (bpm) | Standard Deviation 10.5 |
Secondary
Change From Baseline in Respiratory Rate at Indicated Time Points
Respiratory rate was measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Baseline and up to Day 183
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AVA Alone | Change From Baseline in Respiratory Rate at Indicated Time Points | Day 1, n=286, 280 | -0.4 Breaths per minute | Standard Deviation 1.5 |
| AVA Alone | Change From Baseline in Respiratory Rate at Indicated Time Points | Day 29, n=283, 279 | -0.1 Breaths per minute | Standard Deviation 1.4 |
| AVA Alone | Change From Baseline in Respiratory Rate at Indicated Time Points | Day 57, n=282, 276 | -0.1 Breaths per minute | Standard Deviation 1.5 |
| AVA Alone | Change From Baseline in Respiratory Rate at Indicated Time Points | Day 183, n=273, 266 | -0.3 Breaths per minute | Standard Deviation 1.6 |
| AVA+Raxibacumab | Change From Baseline in Respiratory Rate at Indicated Time Points | Day 183, n=273, 266 | -0.2 Breaths per minute | Standard Deviation 1.5 |
| AVA+Raxibacumab | Change From Baseline in Respiratory Rate at Indicated Time Points | Day 1, n=286, 280 | -0.3 Breaths per minute | Standard Deviation 1.5 |
| AVA+Raxibacumab | Change From Baseline in Respiratory Rate at Indicated Time Points | Day 57, n=282, 276 | -0.1 Breaths per minute | Standard Deviation 1.3 |
| AVA+Raxibacumab | Change From Baseline in Respiratory Rate at Indicated Time Points | Day 29, n=283, 279 | -0.1 Breaths per minute | Standard Deviation 1.4 |
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP and DBP were measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Baseline and up to Day 183
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AVA Alone | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 1, n=286, 280 | -3.4 Millimeter of mercury (mmHg) | Standard Deviation 9.2 |
| AVA Alone | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 29, n=283, 279 | 0.6 Millimeter of mercury (mmHg) | Standard Deviation 9.9 |
| AVA Alone | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 57, n=282, 275 | 1.8 Millimeter of mercury (mmHg) | Standard Deviation 10.9 |
| AVA Alone | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 183, n=273, 266 | 2.4 Millimeter of mercury (mmHg) | Standard Deviation 10.6 |
| AVA Alone | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 1, n=286, 280 | -2.7 Millimeter of mercury (mmHg) | Standard Deviation 6.9 |
| AVA Alone | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 29, n=283, 279 | 1.0 Millimeter of mercury (mmHg) | Standard Deviation 7.3 |
| AVA Alone | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 57, n=282, 275 | 1.9 Millimeter of mercury (mmHg) | Standard Deviation 7.4 |
| AVA Alone | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 183, n=273, 266 | 2.3 Millimeter of mercury (mmHg) | Standard Deviation 8.4 |
| AVA+Raxibacumab | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 183, n=273, 266 | 2.5 Millimeter of mercury (mmHg) | Standard Deviation 7.9 |
| AVA+Raxibacumab | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 1, n=286, 280 | -3.8 Millimeter of mercury (mmHg) | Standard Deviation 9.6 |
| AVA+Raxibacumab | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 1, n=286, 280 | -3.1 Millimeter of mercury (mmHg) | Standard Deviation 6.8 |
| AVA+Raxibacumab | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 29, n=283, 279 | 1.9 Millimeter of mercury (mmHg) | Standard Deviation 9.9 |
| AVA+Raxibacumab | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 57, n=282, 275 | 2.3 Millimeter of mercury (mmHg) | Standard Deviation 7.4 |
| AVA+Raxibacumab | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 57, n=282, 275 | 2.2 Millimeter of mercury (mmHg) | Standard Deviation 10.3 |
| AVA+Raxibacumab | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 29, n=283, 279 | 1.6 Millimeter of mercury (mmHg) | Standard Deviation 6.5 |
| AVA+Raxibacumab | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 183, n=273, 266 | 1.5 Millimeter of mercury (mmHg) | Standard Deviation 9.9 |
Secondary
Change From Baseline in Temperature at Indicated Time Points
Temperature was measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Baseline and up to Day 183
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AVA Alone | Change From Baseline in Temperature at Indicated Time Points | Day 1, n=286, 280 | -0.04 Degree celsius | Standard Deviation 0.26 |
| AVA Alone | Change From Baseline in Temperature at Indicated Time Points | Day 29, n=283, 279 | -0.04 Degree celsius | Standard Deviation 0.24 |
| AVA Alone | Change From Baseline in Temperature at Indicated Time Points | Day 57, n=282, 276 | -0.05 Degree celsius | Standard Deviation 0.25 |
| AVA Alone | Change From Baseline in Temperature at Indicated Time Points | Day 183, n=272, 266 | -0.04 Degree celsius | Standard Deviation 0.277 |
| AVA+Raxibacumab | Change From Baseline in Temperature at Indicated Time Points | Day 183, n=272, 266 | -0.01 Degree celsius | Standard Deviation 0.26 |
| AVA+Raxibacumab | Change From Baseline in Temperature at Indicated Time Points | Day 1, n=286, 280 | 0.02 Degree celsius | Standard Deviation 0.27 |
| AVA+Raxibacumab | Change From Baseline in Temperature at Indicated Time Points | Day 57, n=282, 276 | -0.02 Degree celsius | Standard Deviation 0.25 |
| AVA+Raxibacumab | Change From Baseline in Temperature at Indicated Time Points | Day 29, n=283, 279 | -0.03 Degree celsius | Standard Deviation 0.31 |
Secondary
Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE resulting in death, is life threatening (ie, an immediate threat to life), inpatient hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or any other situation which is medically important and may jeopardize the participant or may require medical or surgical intervention or events associated with liver injury and impaired liver function is categorized as SAE. The Safety population was comprised of all randomized participants who received at least one dose of AVA.
Time frame: Up to Day 183
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AVA Alone | Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (AE) | Non-serious AEs | 85 Participants |
| AVA Alone | Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (AE) | SAE | 5 Participants |
| AVA+Raxibacumab | Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (AE) | Non-serious AEs | 80 Participants |
| AVA+Raxibacumab | Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (AE) | SAE | 3 Participants |
Secondary
Number of Participants With Clinical Chemistry Parameters Outside Normal Range
Blood samples were collected to evaluate clinical chemistry parameters, which included assessment of urea nitrogen (UN), creatinine, chloride, glucose, magnesium, total protein, potassium, chloride, total Carbon dioxide (CO2), sodium, calcium (cal), alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltransferase (GGT), total and direct bilirubin ( D.bili), albumin and calculated creatinine clearance. Here high is equal to above the upper limit of the normal range, low is equal to below the lower limit of the normal range. Participants are counted in the category that their value changes to (low, normal or high), unless there is no change in their category. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Up to Day 57
Population: Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | D.bili µmol/L, Low, Week 8, n=274, 261 | 0 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Albumin g/L, High, Week 4, n=283, 279 | 1 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Albumin g/L, Low, Week 8, n=282, 275 | 2 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Albumin g/L, High, Week 8, n=282, 275 | 0 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | ALP units/liter (U/L), Low, Week 4, n=283, 279 | 3 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | ALP U/L, High, Week 4, n=283, 279 | 14 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | ALP U/L, Low, Week 8, n=282, 275 | 2 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | ALP U/L, High, Week 8, n=282, 275 | 13 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | ALT U/L, Low, Week 4, n=283, 279 | 45 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | ALT U/L, High, Week 4, n=283, 279 | 7 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | ALT U/L, Low, Week 8, n=282, 275 | 39 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | ALT U/L, High, Week 8, n=282, 275 | 7 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | AST U/L, Low, Week 4, n=283, 279 | 41 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | AST U/L, High, Week 4, n=283, 279 | 7 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | AST U/L, Low, Week 8, n=282, 275 | 38 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | AST U/L, High, Week 8, n=282, 275 | 6 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | D.bili micromole/Liter (µmol/L) LowWeek4,n=274,263 | 0 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | D.bili µmol/L, High, Week 4, n=274, 263 | 5 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Albumin g/L, Low, Week 4, n=283, 279 | 6 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | D.bili µmol/L, High, Week 8, n=274, 261 | 5 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Bili µmol/L, Low, Week 4, n=280, 279 | 5 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Bili µmol/L, High, Week 4, n=280, 279 | 1 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Bili µmol/L, Low, Week 8, n=280, 273 | 3 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Bili µmol/L, High, Week 8, n=280, 273 | 2 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Cal,millimole/Liter (mmol/L)Low,Week 4,n=283, 279 | 6 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Cal mmol/L, High, Week 4, n=283, 279 | 2 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Cal mmol/L, Low, Week 8, n=282, 275 | 12 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Cal mmol/L, High, Week 8, n=282, 275 | 0 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Chloride mmol/L, Low, Week 4, n=283, 279 | 0 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Chloride mmol/L, High, Week 4, n=283, 279 | 19 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Chloride mmol/L, Low, Week 8, n=282, 275 | 0 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Chloride mmol/L, High, Week 8, n=282, 275 | 12 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | CO2 mmol/L, Low, Week 4, n=283, 279 | 7 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | CO2 mmol/L, High, Week 4, n=283, 279 | 14 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | CO2 mmol/L, Low, Week 8, n=282, 275 | 6 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | CO2 mmol/L, High, Week 8, n=282, 275 | 10 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Creatinine µmol/L, Low, Week 4, n=283, 279 | 19 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Creatinine µmol/L, High, Week 4, n=283, 279 | 6 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Creatinine µmol/L, Low, Week 8, n=282, 275 | 20 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Creatinine µmol/L, High, Week 8, n=282, 275 | 7 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | GGT U/L, Low, Week 4, n=283, 279 | 8 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | GGT U/L, High, Week 4, n=283, 279 | 4 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | GGT U/L, Low, Week 8, n=282, 275 | 10 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | GGT U/L, High, Week 8, n=282, 275 | 4 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Glucose mmol/L, Low, Week 4, n=283, 279 | 17 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Glucose mmol/L, High, Week 4, n=283, 279 | 16 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Glucose mmol/L, Low, Week 8, n=282, 275 | 16 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Glucose mmol/L, High, Week 8, n=282, 275 | 21 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Potassium mmol/L, Low, Week 4, n=283, 279 | 3 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Potassium mmol/L, High, Week 4, n=283, 279 | 1 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Potassium mmol/L, Low, Week 8, n=282, 275 | 1 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Potassium mmol/L, High, Week 8, n=282, 275 | 2 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Magnesium mmol/L, Low, Week 4, n=283, 279 | 0 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Magnesium mmol/L, High, Week 4, n=283, 279 | 0 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Magnesium mmol/L, Low, Week 8, n=282, 275 | 0 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Magnesium mmol/L, High, Week 8, n=282, 275 | 0 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Protein g/L, Low, Week 4, n=283, 279 | 16 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Protein g/L, High, Week 4, n=283, 279 | 1 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Protein g/L, Low, Week 8, n=282, 275 | 16 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Protein g/L, High, Week 8, n=282, 275 | 4 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Sodium mmol/L, Low, Week 4, n=283, 279 | 3 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Sodium mmol/L, High, Week 4, n=283, 279 | 1 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Sodium mmol/L, Low, Week 8, n=282, 275 | 5 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Sodium mmol/L, High, Week 8, n=282, 275 | 2 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Urate µmol/L, Low, Week 4, n=283, 279 | 5 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Urate µmol/L, High, Week 4, n=283, 279 | 4 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Urate µmol/L, Low, Week 8, n=282, 275 | 9 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Urate µmol/L, High, Week 8, n=282, 275 | 4 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | UN mmol/L, Low, Week 4, n=283, 279 | 3 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | UN mmol/L, High, Week 4, n=283, 279 | 9 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | UN mmol/L, Low, Week 8, n=282, 275 | 3 Participants |
| AVA Alone | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | UN mmol/L, High, Week 8, n=282, 275 | 8 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Urate µmol/L, High, Week 8, n=282, 275 | 4 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Albumin g/L, Low, Week 4, n=283, 279 | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Creatinine µmol/L, Low, Week 4, n=283, 279 | 10 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Albumin g/L, High, Week 4, n=283, 279 | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Magnesium mmol/L, Low, Week 8, n=282, 275 | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Albumin g/L, Low, Week 8, n=282, 275 | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Creatinine µmol/L, High, Week 4, n=283, 279 | 3 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Albumin g/L, High, Week 8, n=282, 275 | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Sodium mmol/L, High, Week 8, n=282, 275 | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | ALP units/liter (U/L), Low, Week 4, n=283, 279 | 5 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Creatinine µmol/L, Low, Week 8, n=282, 275 | 10 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | ALP U/L, High, Week 4, n=283, 279 | 20 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Magnesium mmol/L, High, Week 8, n=282, 275 | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | ALP U/L, Low, Week 8, n=282, 275 | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Creatinine µmol/L, High, Week 8, n=282, 275 | 5 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | ALP U/L, High, Week 8, n=282, 275 | 19 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | UN mmol/L, High, Week 8, n=282, 275 | 7 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | ALT U/L, Low, Week 4, n=283, 279 | 44 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | GGT U/L, Low, Week 4, n=283, 279 | 3 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | ALT U/L, High, Week 4, n=283, 279 | 4 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Protein g/L, Low, Week 4, n=283, 279 | 17 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | ALT U/L, Low, Week 8, n=282, 275 | 42 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | GGT U/L, High, Week 4, n=283, 279 | 3 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | ALT U/L, High, Week 8, n=282, 275 | 6 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Urate µmol/L, Low, Week 4, n=283, 279 | 5 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | AST U/L, Low, Week 4, n=283, 279 | 37 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | GGT U/L, Low, Week 8, n=282, 275 | 6 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | AST U/L, High, Week 4, n=283, 279 | 5 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Protein g/L, High, Week 4, n=283, 279 | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | AST U/L, Low, Week 8, n=282, 275 | 34 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | GGT U/L, High, Week 8, n=282, 275 | 9 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | AST U/L, High, Week 8, n=282, 275 | 10 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | UN mmol/L, Low, Week 4, n=283, 279 | 4 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | D.bili micromole/Liter (µmol/L) LowWeek4,n=274,263 | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Glucose mmol/L, Low, Week 4, n=283, 279 | 14 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | D.bili µmol/L, High, Week 4, n=274, 263 | 3 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Protein g/L, Low, Week 8, n=282, 275 | 9 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | D.bili µmol/L, Low, Week 8, n=274, 261 | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Glucose mmol/L, High, Week 4, n=283, 279 | 31 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | D.bili µmol/L, High, Week 8, n=274, 261 | 9 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Urate µmol/L, High, Week 4, n=283, 279 | 5 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Bili µmol/L, Low, Week 4, n=280, 279 | 4 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Glucose mmol/L, Low, Week 8, n=282, 275 | 16 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Bili µmol/L, High, Week 4, n=280, 279 | 5 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Protein g/L, High, Week 8, n=282, 275 | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Bili µmol/L, Low, Week 8, n=280, 273 | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Glucose mmol/L, High, Week 8, n=282, 275 | 12 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Bili µmol/L, High, Week 8, n=280, 273 | 7 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | UN mmol/L, Low, Week 8, n=282, 275 | 6 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Cal,millimole/Liter (mmol/L)Low,Week 4,n=283, 279 | 4 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Potassium mmol/L, Low, Week 4, n=283, 279 | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Cal mmol/L, High, Week 4, n=283, 279 | 4 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Sodium mmol/L, Low, Week 4, n=283, 279 | 6 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Cal mmol/L, Low, Week 8, n=282, 275 | 10 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Potassium mmol/L, High, Week 4, n=283, 279 | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Cal mmol/L, High, Week 8, n=282, 275 | 3 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Urate µmol/L, Low, Week 8, n=282, 275 | 7 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Chloride mmol/L, Low, Week 4, n=283, 279 | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Potassium mmol/L, Low, Week 8, n=282, 275 | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Chloride mmol/L, High, Week 4, n=283, 279 | 12 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Sodium mmol/L, High, Week 4, n=283, 279 | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Chloride mmol/L, Low, Week 8, n=282, 275 | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Potassium mmol/L, High, Week 8, n=282, 275 | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Chloride mmol/L, High, Week 8, n=282, 275 | 9 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | UN mmol/L, High, Week 4, n=283, 279 | 7 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | CO2 mmol/L, Low, Week 4, n=283, 279 | 11 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Magnesium mmol/L, Low, Week 4, n=283, 279 | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | CO2 mmol/L, High, Week 4, n=283, 279 | 12 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Sodium mmol/L, Low, Week 8, n=282, 275 | 6 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | CO2 mmol/L, Low, Week 8, n=282, 275 | 14 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Magnesium mmol/L, High, Week 4, n=283, 279 | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | CO2 mmol/L, High, Week 8, n=282, 275 | 9 Participants |
Secondary
Number of Participants With Hematology Parameters Outside Normal Range
Hematology parameters included assessment of platelet count, erythrocytes, leukocytes , reticulocyte count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils, basophils, hemoglobin and hematocrit. Here high is equal to above the upper limit of the normal range, low is equal to below the lower limit of the normal range. Participants are counted in the category that their value changes to (low, normal or high), unless there is no change in their category. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Up to Day 57
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Hemoglobin g/L, Low, Week 8, n=281, 276 | 7 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Eosinophils 10^9/L High, Week 4, n=282, 278 | 4 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Eosinophils 10^9/L, Low, Week 8, n=281, 276 | 0 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Eosinophils 10^9/L, High, Week 8, n=281, 276 | 7 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Basophils 10^9/L, Low, Week 4, n=282, 278 | 0 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Basophils 10^9/L, High, Week 4, n=282, 278 | 0 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Basophils 10^9/L, Low, Week 8, n=281, 276 | 0 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Basophils 10^9/L, High, Week 8, n=281, 276 | 0 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Hematocrit percent (%) Low, Week 4, n=283, 279 | 7 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Hematocrit %, High, Week 4, n=283, 279 | 2 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Hematocrit %, Low, Week 8, n=281, 276 | 6 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Hematocrit %, High, Week 8, n=281, 276 | 2 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Hemoglobin gram/Liter (g/L) Low,Week 4,n=283, 279 | 7 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Hemoglobin g/L, High, Week 4, n=283, 279 | 4 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Eosinophils 10^9/Liter (L) Low, Week 4, n=282, 278 | 0 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Hemoglobin g/L, High, Week 8, n=281, 276 | 3 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Lymphocytes 10^9/L , Low, Week 4, n=282, 278 | 3 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Lymphocytes 10^9/L , High, Week 4, n=282, 278 | 0 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Lymphocytes 10^9/L, Low, Week 8, n=281, 276 | 2 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Lymphocytes 10^9/L, High, Week 8, n=281, 276 | 0 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | MCH picogram (pg), Low, Week 4, n=283, 279 | 2 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | MCH pg, High, Week 4, n=283, 279 | 0 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Monocytes 10^9/L, Low, Week 8, n=281, 276 | 0 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | MCH pg, Low, Week 8, n=281, 276 | 2 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | MCH pg, High, Week 8, n=281, 276 | 0 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | MCHC g/L, Low, Week 4, n=283, 279 | 3 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | MCHC g/L, High, Week 4, n=283, 279 | 19 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | MCHC g/L, Low, Week 8, n=281, 276 | 3 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | MCHC g/L, High, Week 8, n=281, 276 | 16 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | MCV femtoliters (fL), Low, Week 4, n=283, 279 | 2 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | MCV fL, High, Week 4, n=283, 279 | 0 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | MCV fL, Low, Week 8, n=281, 276 | 3 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | MCV fL, High, Week 8, n=281, 276 | 0 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Monocytes 10^9/L , Low, Week 4, n=282, 278 | 0 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Monocytes 10^9/L, High, Week 4, n=282, 278 | 3 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Monocytes 10^9/L, High, Week 8, n=281, 276 | 0 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Neutrophils 10^9/L, Low, Week 4, n=283, 279 | 7 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Neutrophils 10^9/L, High, Week 4, n=283, 279 | 3 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Neutrophils 10^9/L, Low, Week 8, n=281, 276 | 5 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Neutrophils 10^9/L, High, Week 8, n=281, 276 | 1 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Erythrocytes 10^12/L, Low, Week 4, n=283, 279 | 6 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Erythrocytes 10^12/L, High, Week 4, n=283, 279 | 4 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Erythrocytes 10^12/L, Low, Week 8, n=281, 276 | 2 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Erythrocytes 10^12/L, High, Week 8, n=281, 276 | 6 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Leukocytes 10^9/L, Low, Week 4, n=283, 279 | 15 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Leukocytes 10^9/L, High, Week 4, n=283, 279 | 2 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Leukocytes 10^9/L, Low, Week 8, n=281, 276 | 6 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Leukocytes 10^9/L, High, Week 8, n=281, 276 | 1 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Reticulocytes 10^12/L, Low, Week 4, n=283, 279 | 1 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Reticulocytes 10^12/L, High, Week 4, n=283, 279 | 1 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Reticulocytes 10^12/L, Low, Week 8, n=281, 276 | 1 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Reticulocytes 10^12/L, High, Week 8, n=281, 276 | 5 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Platelet 10^9/L, Low, Week 4, n=282, 279 | 6 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Platelet 10^9/L, High, Week 4, n=282, 279 | 0 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Platelet 10^9/L, Low, Week 8, n=280, 276 | 4 Participants |
| AVA Alone | Number of Participants With Hematology Parameters Outside Normal Range | Platelet 10^9/L, High, Week 8, n=280, 276 | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | MCHC g/L, High, Week 8, n=281, 276 | 12 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Eosinophils 10^9/Liter (L) Low, Week 4, n=282, 278 | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Erythrocytes 10^12/L, Low, Week 8, n=281, 276 | 8 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Eosinophils 10^9/L High, Week 4, n=282, 278 | 6 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | MCV femtoliters (fL), Low, Week 4, n=283, 279 | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Eosinophils 10^9/L, Low, Week 8, n=281, 276 | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Reticulocytes 10^12/L, High, Week 4, n=283, 279 | 3 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Eosinophils 10^9/L, High, Week 8, n=281, 276 | 5 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | MCV fL, High, Week 4, n=283, 279 | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Basophils 10^9/L, Low, Week 4, n=282, 278 | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Erythrocytes 10^12/L, High, Week 8, n=281, 276 | 3 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Basophils 10^9/L, High, Week 4, n=282, 278 | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | MCV fL, Low, Week 8, n=281, 276 | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Basophils 10^9/L, Low, Week 8, n=281, 276 | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Platelet 10^9/L, Low, Week 8, n=280, 276 | 4 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Basophils 10^9/L, High, Week 8, n=281, 276 | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | MCV fL, High, Week 8, n=281, 276 | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Hematocrit percent (%) Low, Week 4, n=283, 279 | 6 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Leukocytes 10^9/L, Low, Week 4, n=283, 279 | 12 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Hematocrit %, High, Week 4, n=283, 279 | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Monocytes 10^9/L , Low, Week 4, n=282, 278 | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Hematocrit %, Low, Week 8, n=281, 276 | 9 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Reticulocytes 10^12/L, Low, Week 8, n=281, 276 | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Hematocrit %, High, Week 8, n=281, 276 | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Monocytes 10^9/L, High, Week 4, n=282, 278 | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Hemoglobin gram/Liter (g/L) Low,Week 4,n=283, 279 | 3 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Monocytes 10^9/L, Low, Week 8, n=281, 276 | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Hemoglobin g/L, High, Week 4, n=283, 279 | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Leukocytes 10^9/L, High, Week 4, n=283, 279 | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Hemoglobin g/L, Low, Week 8, n=281, 276 | 10 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Monocytes 10^9/L, High, Week 8, n=281, 276 | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Hemoglobin g/L, High, Week 8, n=281, 276 | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Platelet 10^9/L, High, Week 4, n=282, 279 | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Lymphocytes 10^9/L , Low, Week 4, n=282, 278 | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Neutrophils 10^9/L, Low, Week 4, n=283, 279 | 8 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Lymphocytes 10^9/L , High, Week 4, n=282, 278 | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Leukocytes 10^9/L, Low, Week 8, n=281, 276 | 10 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Lymphocytes 10^9/L, Low, Week 8, n=281, 276 | 4 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Neutrophils 10^9/L, High, Week 4, n=283, 279 | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Lymphocytes 10^9/L, High, Week 8, n=281, 276 | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Reticulocytes 10^12/L, High, Week 8, n=281, 276 | 3 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | MCH picogram (pg), Low, Week 4, n=283, 279 | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Neutrophils 10^9/L, Low, Week 8, n=281, 276 | 6 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Leukocytes 10^9/L, High, Week 8, n=281, 276 | 5 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | MCH pg, High, Week 4, n=283, 279 | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Neutrophils 10^9/L, High, Week 8, n=281, 276 | 6 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | MCH pg, Low, Week 8, n=281, 276 | 5 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Platelet 10^9/L, High, Week 8, n=280, 276 | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | MCH pg, High, Week 8, n=281, 276 | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Erythrocytes 10^12/L, Low, Week 4, n=283, 279 | 4 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | MCHC g/L, Low, Week 4, n=283, 279 | 3 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Reticulocytes 10^12/L, Low, Week 4, n=283, 279 | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | MCHC g/L, High, Week 4, n=283, 279 | 17 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Erythrocytes 10^12/L, High, Week 4, n=283, 279 | 7 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | MCHC g/L, Low, Week 8, n=281, 276 | 7 Participants |
| AVA+Raxibacumab | Number of Participants With Hematology Parameters Outside Normal Range | Platelet 10^9/L, Low, Week 4, n=282, 279 | 4 Participants |
Secondary
Number of Participants With Urinalysis Parameters
Urinalysis parameters included amorphous crystals, bacteria, bilirubin, calcium oxalate (Ca Ox) crystals, choriogonadotropin beta, clarity, color, crystals of Ca Ox, erythrocytes, glucose, hemoglobin, ketone bodies, ketones, leukocyte cell clumps, leukocyte esterase, leukocytes, mucous threads, nitrite, occult blood, protein, specific gravity, squamous epithelial cells, turbidity, urobilinogen, and transitional epithelial cells. In urinalysis test plus sign (+) indicates increase in the level of the parameters.
Time frame: Day 57
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AVA Alone | Number of Participants With Urinalysis Parameters | Crystals Ca-Ox | 9 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Bacteria mod | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Bacteria Occ | 3 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Bacteria many | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Amorphous crystals 1+ | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Amorphous crystals 2+ | 7 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Amorphous crystals 3+ | 0 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Amorphous crystals 4+ | 3 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Amorphous crystals trace | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Bacteria 1+ | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Bacteria 2+ | 2 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Bacteria 3+ | 0 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Bacteria 4+ | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Bacteria few | 2 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Bacteria rare | 5 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Bacteria trace | 2 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Bilirubin 1+ | 2 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Bilirubin negative | 196 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Bilirubin small | 0 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Ca Ox Crystals few | 0 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Ca Ox Crystals rare | 2 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Choriogonadotropin Beta negative | 24 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Choriogonadotropin Beta positive | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Clarity, clear | 38 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Clarity, cloudy | 8 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Clarity turbid | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Color amber | 2 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Color colorless | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Color light-red | 0 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Color light-yellow | 6 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Color yellow | 74 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Erythrocytes 0-2 | 107 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Erythrocytes 10-25 | 3 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Erythrocytes 2-5 | 2 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Erythrocytes 25-50 | 0 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Erythrocytes 5-10 | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Erythrocytes 50-99 | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Erythrocytes innumerable | 0 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Erythrocytes less than 1 | 10 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Erythrocytes Tntc | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Glucose positive | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Glucose negative | 257 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Hemoglobin + | 13 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Hemoglobin ++ | 0 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Hemoglobin +++ | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Hemoglobin large | 4 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Hemoglobin mod | 3 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Hemoglobin negative | 174 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Hemoglobin small | 13 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Hemoglobin trace | 2 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Ketone bodies negative | 114 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Ketone bodies trace | 0 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Ketones + | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Ketones ++ | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Ketones ++++ | 0 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Leukocyte less than 1 | 8 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Ketones mod | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Ketones negative | 255 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Ketones trace | 0 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Leukocyte Cell Clumps Occ | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Leukocyte Cell Clumps rare | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Leukocyte Esterase 1+ | 4 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Leukocyte Esterase 2+ | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Leukocyte Esterase 3+ | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Leukocyte Esterase large | 10 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Leukocyte Esterase Mod | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Leukocyte Esterase Moderate | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Leukocyte Esterase negative | 162 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Leukocyte Esterase small | 5 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Leukocyte Esterase trace | 13 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Leukocyte + | 5 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Leukocyte ++ | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Leukocyte +++ | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Leukocyte 0-2 | 105 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Leukocyte 10-25 | 2 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Leukocyte 2-5 | 6 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Leukocyte 25-50 | 0 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Leukocyte 5-10 | 2 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Leukocyte large | 4 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Leukocyte mod | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Leukocyte negative | 187 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Leukocyte small | 2 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Leukocyte trace | 9 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Mucous threads 2+ | 0 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Mucous Threads few | 24 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Mucous Threads many | 2 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Mucous Threads Mod | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Mucous Threads trace | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Nitrite negative | 190 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Nitrite positive | 8 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Occult Blood 1+ | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Occult Blood 2+ | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Occult Blood 3+ | 0 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Occult Blood large | 5 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Occult Blood mod | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Occult Blood moderate | 2 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Occult Blood negative | 163 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Occult Blood small | 22 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Occult Blood trace | 3 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Protein + | 7 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Protein ++ | 2 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Protein ++++ | 0 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Protein 1+ | 3 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Protein large | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Protein negative | 244 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Protein non-heam | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Protein trace | 12 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Specific Gravity <=1.005 | 1 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Specific Gravity >=1.030 | 3 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Squamous Epithelial Cells 0-2 | 8 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Squamous Epithelial Cells 2-5 | 2 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Squamous Epithelial Cells 5-10 | 2 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Squamous Epithelial Cells <1 | 9 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Turbidity clear | 15 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Turbidity cloudy | 2 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Turbidity hazy | 19 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Urobilinogen <2.0 | 113 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Urobilinogen less than 2.0 | 33 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Urobilinogen normal | 47 Participants |
| AVA Alone | Number of Participants With Urinalysis Parameters | Transitional Epithelial Cells <1 | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Squamous Epithelial Cells <1 | 8 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Leukocyte Cell Clumps rare | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Bacteria mod | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Occult Blood 1+ | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Bacteria Occ | 7 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Leukocyte Esterase 1+ | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Protein non-heam | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Amorphous crystals 1+ | 5 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Leukocyte Esterase 2+ | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Amorphous crystals 2+ | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Occult Blood 2+ | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Amorphous crystals 3+ | 3 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Leukocyte Esterase 3+ | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Amorphous crystals 4+ | 4 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Urobilinogen <2.0 | 111 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Amorphous crystals trace | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Leukocyte Esterase large | 7 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Bacteria 1+ | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Occult Blood 3+ | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Bacteria 2+ | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Leukocyte Esterase Mod | 3 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Bacteria 3+ | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Protein trace | 15 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Bacteria 4+ | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Leukocyte Esterase Moderate | 4 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Bacteria few | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Occult Blood large | 3 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Bacteria rare | 8 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Leukocyte Esterase negative | 159 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Bacteria trace | 3 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Turbidity clear | 15 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Bilirubin 1+ | 3 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Leukocyte Esterase small | 7 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Bilirubin negative | 188 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Occult Blood mod | 5 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Bilirubin small | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Leukocyte Esterase trace | 10 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Ca Ox Crystals few | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Specific Gravity <=1.005 | 5 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Ca Ox Crystals rare | 3 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Leukocyte + | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Choriogonadotropin Beta negative | 16 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Occult Blood moderate | 7 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Choriogonadotropin Beta positive | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Leukocyte ++ | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Clarity, clear | 44 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Urobilinogen normal | 46 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Clarity, cloudy | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Leukocyte +++ | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Clarity turbid | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Occult Blood negative | 148 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Color amber | 5 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Leukocyte 0-2 | 99 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Color colorless | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Specific Gravity >=1.030 | 6 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Color light-red | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Leukocyte 10-25 | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Color light-yellow | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Occult Blood small | 21 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Color yellow | 71 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Bacteria many | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Crystals Ca-Ox | 17 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Leukocyte 2-5 | 7 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Erythrocytes 0-2 | 104 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Turbidity cloudy | 3 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Erythrocytes 10-25 | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Leukocyte 25-50 | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Erythrocytes 2-5 | 6 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Occult Blood trace | 6 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Erythrocytes 25-50 | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Leukocyte 5-10 | 4 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Leukocyte less than 1 | 5 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Erythrocytes 5-10 | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Squamous Epithelial Cells 0-2 | 3 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Erythrocytes 50-99 | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Leukocyte large | 5 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Erythrocytes innumerable | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Protein + | 10 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Erythrocytes less than 1 | 4 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Leukocyte mod | 5 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Erythrocytes Tntc | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Urobilinogen less than 2.0 | 31 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Glucose positive | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Leukocyte negative | 188 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Glucose negative | 257 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Protein ++ | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Hemoglobin + | 18 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Leukocyte small | 5 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Hemoglobin ++ | 3 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Squamous Epithelial Cells 2-5 | 5 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Hemoglobin +++ | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Leukocyte trace | 7 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Hemoglobin large | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Protein ++++ | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Hemoglobin mod | 6 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Mucous threads 2+ | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Hemoglobin negative | 166 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Turbidity hazy | 16 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Hemoglobin small | 13 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Mucous Threads few | 25 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Hemoglobin trace | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Protein 1+ | 4 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Ketone bodies negative | 106 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Mucous Threads many | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Ketone bodies trace | 4 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Squamous Epithelial Cells 5-10 | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Ketones + | 1 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Mucous Threads Mod | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Ketones ++ | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Protein large | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Mucous Threads trace | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Ketones ++++ | 2 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Transitional Epithelial Cells <1 | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Ketones mod | 0 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Nitrite negative | 190 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Ketones negative | 247 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Protein negative | 238 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Ketones trace | 7 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Nitrite positive | 3 Participants |
| AVA+Raxibacumab | Number of Participants With Urinalysis Parameters | Leukocyte Cell Clumps Occ | 0 Participants |
Secondary
Percentage of Participants Who Seroconvert, at Weeks 4, 8, and 26 (Days 29, 57 and 183) After the First AVA Dose, Between the AVA Alone and the AVA With Raxibacumab Treatment Groups
The percentage of participants, with corresponding 95% CI based on Wilson's method, who seroconvert (seroconversion is defined as a \>4-fold increase in toxin neutralizing activity \[TNA\] titer) was summarized, at Weeks 4, 8 and 26 after the first AVA dose for both arms separately. Serum TNA titer was determined using a cell-based assay.
Time frame: Days 29, 57 and 183
Population: PP Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AVA Alone | Percentage of Participants Who Seroconvert, at Weeks 4, 8, and 26 (Days 29, 57 and 183) After the First AVA Dose, Between the AVA Alone and the AVA With Raxibacumab Treatment Groups | Week 4 | 76.4 Percent of Participants |
| AVA Alone | Percentage of Participants Who Seroconvert, at Weeks 4, 8, and 26 (Days 29, 57 and 183) After the First AVA Dose, Between the AVA Alone and the AVA With Raxibacumab Treatment Groups | Week 8 | 95.3 Percent of Participants |
| AVA Alone | Percentage of Participants Who Seroconvert, at Weeks 4, 8, and 26 (Days 29, 57 and 183) After the First AVA Dose, Between the AVA Alone and the AVA With Raxibacumab Treatment Groups | Week 26 | 31.9 Percent of Participants |
| AVA+Raxibacumab | Percentage of Participants Who Seroconvert, at Weeks 4, 8, and 26 (Days 29, 57 and 183) After the First AVA Dose, Between the AVA Alone and the AVA With Raxibacumab Treatment Groups | Week 4 | 99.3 Percent of Participants |
| AVA+Raxibacumab | Percentage of Participants Who Seroconvert, at Weeks 4, 8, and 26 (Days 29, 57 and 183) After the First AVA Dose, Between the AVA Alone and the AVA With Raxibacumab Treatment Groups | Week 8 | 98.1 Percent of Participants |
| AVA+Raxibacumab | Percentage of Participants Who Seroconvert, at Weeks 4, 8, and 26 (Days 29, 57 and 183) After the First AVA Dose, Between the AVA Alone and the AVA With Raxibacumab Treatment Groups | Week 26 | 32.0 Percent of Participants |
Secondary
Ratio of GMC of Anti-PA Ab at Weeks 8 and 26 (Days 57 and 183) After the First AVA Dose, Between the AVA Alone and AVA With Raxibacumab Treatment Groups
Anti-PA antibody concentrations were collected at Weeks 8 and 26 after the first AVA dose. Serum AVA derived anti-PA Ab concentrations were determined using an approved immunoassay. The GMCs with corresponding 95% CI were calculated for each treatment group at each timepoint. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Days 57 and 183
Population: PP Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| AVA Alone | Ratio of GMC of Anti-PA Ab at Weeks 8 and 26 (Days 57 and 183) After the First AVA Dose, Between the AVA Alone and AVA With Raxibacumab Treatment Groups | Week 8, n=275, 267 | 50.470 µg/mL |
| AVA Alone | Ratio of GMC of Anti-PA Ab at Weeks 8 and 26 (Days 57 and 183) After the First AVA Dose, Between the AVA Alone and AVA With Raxibacumab Treatment Groups | Week 26, n=267, 258 | 10.007 µg/mL |
| AVA+Raxibacumab | Ratio of GMC of Anti-PA Ab at Weeks 8 and 26 (Days 57 and 183) After the First AVA Dose, Between the AVA Alone and AVA With Raxibacumab Treatment Groups | Week 8, n=275, 267 | 46.095 µg/mL |
| AVA+Raxibacumab | Ratio of GMC of Anti-PA Ab at Weeks 8 and 26 (Days 57 and 183) After the First AVA Dose, Between the AVA Alone and AVA With Raxibacumab Treatment Groups | Week 26, n=267, 258 | 10.231 µg/mL |
90% CI: [0.98, 1.22]t-test, 1 sided
p-value: <0.000190% CI: [0.89, 1.07]t-test, 1 sided