Trial Outcomes & Findings for Effect of Raxibacumab on Immunogenicity of Anthrax Vaccine Adsorbed (NCT NCT02339155)

Last Updated: 2024-03-18

Results Overview

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 \[anti-PA Ab concentration at Week 4\]).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

573 participants

Primary outcome timeframe

Day 29

Results posted on

2024-03-18

Participant Flow

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.

A total of 573 participants were randomized with 566 receiving study treatment and 537 completed the study.

Participant milestones

Participant milestones
Measure	AVA Alone Participants administered Anthrax vaccine adsorbed (AVA) subcutaneous (SC) 0.5 milliliter (mL) on Days 1, 15 and 29	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 milligram/kilogram (mg/kg) intravenous (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.
Overall Study STARTED	287	286
Overall Study Received Study Treatment	286	280
Overall Study COMPLETED	272	265
Overall Study NOT COMPLETED	15	21

Reasons for withdrawal

Reasons for withdrawal
Measure	AVA Alone Participants administered Anthrax vaccine adsorbed (AVA) subcutaneous (SC) 0.5 milliliter (mL) on Days 1, 15 and 29	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 milligram/kilogram (mg/kg) intravenous (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.
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

The ITT Population comprised of all randomized participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AVA Alone n=287 Participants Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29	AVA+Raxibacumab n=286 Participants 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.	Total n=573 Participants Total of all reporting groups
Age, Continuous	36.2 Years STANDARD_DEVIATION 12.78 • n=5 Participants • The ITT Population comprised of all randomized participants	36.1 Years STANDARD_DEVIATION 12.06 • n=7 Participants • The ITT Population comprised of all randomized participants	36.2 Years STANDARD_DEVIATION 12.42 • n=5 Participants • The ITT Population comprised of all randomized participants
Sex: Female, Male Female	150 Participants n=5 Participants • ITT	142 Participants n=7 Participants • ITT	292 Participants n=5 Participants • ITT
Sex: Female, Male Male	137 Participants n=5 Participants • ITT	144 Participants n=7 Participants • ITT	281 Participants n=5 Participants • ITT
Race/Ethnicity, Customized White	216 Participants n=5 Participants • ITT	221 Participants n=7 Participants • ITT	437 Participants n=5 Participants • ITT
Race/Ethnicity, Customized Black or African American	61 Participants n=5 Participants • ITT	56 Participants n=7 Participants • ITT	117 Participants n=5 Participants • ITT
Race/Ethnicity, Customized American Indian or Alaska Native	7 Participants n=5 Participants • ITT	1 Participants n=7 Participants • ITT	8 Participants n=5 Participants • ITT
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants • ITT	5 Participants n=7 Participants • ITT	7 Participants n=5 Participants • ITT
Race/Ethnicity, Customized Multiple	1 Participants n=5 Participants • ITT	2 Participants n=7 Participants • ITT	3 Participants n=5 Participants • ITT
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants • ITT	1 Participants n=7 Participants • ITT	1 Participants n=5 Participants • ITT

PRIMARY outcome

Timeframe: Day 29

Population: PP Population.

Outcome measures

Outcome measures
Measure	AVA Alone n=276 Participants Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29	AVA+Raxibacumab n=269 Participants 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.
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) Interval 23.58 to 29.816	22.477 Microgram/milliliter (µg/mL) Interval 20.098 to 25.137

SECONDARY outcome

Timeframe: Days 57 and 183

Population: PP Population.

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.

Outcome measures

Outcome measures
Measure	AVA Alone n=275 Participants Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29	AVA+Raxibacumab n=267 Participants 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.
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 Interval 46.124 to 55.224	46.095 µg/mL Interval 41.86 to 50.757
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 Interval 9.243 to 10.835	10.231 µg/mL Interval 9.479 to 11.042

SECONDARY outcome

Timeframe: Days 29, 57 and 183

Population: PP Population.

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.

Outcome measures

Outcome measures
Measure	AVA Alone n=276 Participants Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29	AVA+Raxibacumab n=269 Participants 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.
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 Interval 71.1 to 81.1	99.3 Percent of Participants Interval 97.3 to 99.8
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 Interval 92.5 to 97.5	98.1 Percent of Participants Interval 96.7 to 99.6
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 Interval 27.6 to 38.8	32.0 Percent of Participants Interval 27.9 to 39.3

SECONDARY outcome

Timeframe: Up to Day 183

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	AVA Alone n=286 Participants Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29	AVA+Raxibacumab n=280 Participants 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.
Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (AE) Non-serious AEs	85 Participants	80 Participants
Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (AE) SAE	5 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline and up to Day 183

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	AVA Alone n=286 Participants Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29	AVA+Raxibacumab n=280 Participants 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.
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	-3.8 Millimeter of mercury (mmHg) Standard Deviation 9.6
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	1.9 Millimeter of mercury (mmHg) Standard Deviation 9.9
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	2.2 Millimeter of mercury (mmHg) Standard Deviation 10.3
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	1.5 Millimeter of mercury (mmHg) Standard Deviation 9.9
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	-3.1 Millimeter of mercury (mmHg) Standard Deviation 6.8
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	1.6 Millimeter of mercury (mmHg) Standard Deviation 6.5
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	2.3 Millimeter of mercury (mmHg) Standard Deviation 7.4
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	2.5 Millimeter of mercury (mmHg) Standard Deviation 7.9

SECONDARY outcome

Timeframe: Baseline and up to Day 183

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	AVA Alone n=286 Participants Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29	AVA+Raxibacumab n=280 Participants 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.
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	-0.8 Beats per minute (bpm) Standard Deviation 10.5
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	-0.4 Beats per minute (bpm) Standard Deviation 10.5
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	-0.9 Beats per minute (bpm) Standard Deviation 11.2
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	0.7 Beats per minute (bpm) Standard Deviation 11.5

SECONDARY outcome

Timeframe: Baseline and up to Day 183

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	AVA Alone n=286 Participants Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29	AVA+Raxibacumab n=280 Participants 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.
Change From Baseline in Respiratory Rate at Indicated Time Points Day 1, n=286, 280	-0.4 Breaths per minute Standard Deviation 1.5	-0.3 Breaths per minute Standard Deviation 1.5
Change From Baseline in Respiratory Rate at Indicated Time Points Day 29, n=283, 279	-0.1 Breaths per minute Standard Deviation 1.4	-0.1 Breaths per minute Standard Deviation 1.4
Change From Baseline in Respiratory Rate at Indicated Time Points Day 57, n=282, 276	-0.1 Breaths per minute Standard Deviation 1.5	-0.1 Breaths per minute Standard Deviation 1.3
Change From Baseline in Respiratory Rate at Indicated Time Points Day 183, n=273, 266	-0.3 Breaths per minute Standard Deviation 1.6	-0.2 Breaths per minute Standard Deviation 1.5

SECONDARY outcome

Timeframe: Baseline and up to Day 183

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	AVA Alone n=286 Participants Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29	AVA+Raxibacumab n=280 Participants 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.
Change From Baseline in Temperature at Indicated Time Points Day 1, n=286, 280	-0.04 Degree celsius Standard Deviation 0.26	0.02 Degree celsius Standard Deviation 0.27
Change From Baseline in Temperature at Indicated Time Points Day 29, n=283, 279	-0.04 Degree celsius Standard Deviation 0.24	-0.03 Degree celsius Standard Deviation 0.31
Change From Baseline in Temperature at Indicated Time Points Day 57, n=282, 276	-0.05 Degree celsius Standard Deviation 0.25	-0.02 Degree celsius Standard Deviation 0.25
Change From Baseline in Temperature at Indicated Time Points Day 183, n=272, 266	-0.04 Degree celsius Standard Deviation 0.277	-0.01 Degree celsius Standard Deviation 0.26

SECONDARY outcome

Timeframe: Up to Day 57

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	AVA Alone n=286 Participants Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29	AVA+Raxibacumab n=280 Participants 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.
Number of Participants With Hematology Parameters Outside Normal Range MCV fL, Low, Week 8, n=281, 276	3 Participants	2 Participants
Number of Participants With Hematology Parameters Outside Normal Range Eosinophils 10^9/Liter (L) Low, Week 4, n=282, 278	0 Participants	0 Participants
Number of Participants With Hematology Parameters Outside Normal Range Eosinophils 10^9/L High, Week 4, n=282, 278	4 Participants	6 Participants
Number of Participants With Hematology Parameters Outside Normal Range Eosinophils 10^9/L, Low, Week 8, n=281, 276	0 Participants	0 Participants
Number of Participants With Hematology Parameters Outside Normal Range Eosinophils 10^9/L, High, Week 8, n=281, 276	7 Participants	5 Participants
Number of Participants With Hematology Parameters Outside Normal Range Basophils 10^9/L, Low, Week 4, n=282, 278	0 Participants	0 Participants
Number of Participants With Hematology Parameters Outside Normal Range Basophils 10^9/L, High, Week 4, n=282, 278	0 Participants	0 Participants
Number of Participants With Hematology Parameters Outside Normal Range Basophils 10^9/L, Low, Week 8, n=281, 276	0 Participants	0 Participants
Number of Participants With Hematology Parameters Outside Normal Range Basophils 10^9/L, High, Week 8, n=281, 276	0 Participants	0 Participants
Number of Participants With Hematology Parameters Outside Normal Range Hematocrit percent (%) Low, Week 4, n=283, 279	7 Participants	6 Participants
Number of Participants With Hematology Parameters Outside Normal Range Hematocrit %, High, Week 4, n=283, 279	2 Participants	1 Participants
Number of Participants With Hematology Parameters Outside Normal Range Hematocrit %, Low, Week 8, n=281, 276	6 Participants	9 Participants
Number of Participants With Hematology Parameters Outside Normal Range Hematocrit %, High, Week 8, n=281, 276	2 Participants	2 Participants
Number of Participants With Hematology Parameters Outside Normal Range Hemoglobin gram/Liter (g/L) Low,Week 4,n=283, 279	7 Participants	3 Participants
Number of Participants With Hematology Parameters Outside Normal Range Hemoglobin g/L, High, Week 4, n=283, 279	4 Participants	1 Participants
Number of Participants With Hematology Parameters Outside Normal Range Hemoglobin g/L, Low, Week 8, n=281, 276	7 Participants	10 Participants
Number of Participants With Hematology Parameters Outside Normal Range Hemoglobin g/L, High, Week 8, n=281, 276	3 Participants	2 Participants
Number of Participants With Hematology Parameters Outside Normal Range Lymphocytes 10^9/L , Low, Week 4, n=282, 278	3 Participants	1 Participants
Number of Participants With Hematology Parameters Outside Normal Range Lymphocytes 10^9/L , High, Week 4, n=282, 278	0 Participants	1 Participants
Number of Participants With Hematology Parameters Outside Normal Range Lymphocytes 10^9/L, Low, Week 8, n=281, 276	2 Participants	4 Participants
Number of Participants With Hematology Parameters Outside Normal Range Lymphocytes 10^9/L, High, Week 8, n=281, 276	0 Participants	0 Participants
Number of Participants With Hematology Parameters Outside Normal Range MCH picogram (pg), Low, Week 4, n=283, 279	2 Participants	1 Participants
Number of Participants With Hematology Parameters Outside Normal Range MCH pg, High, Week 4, n=283, 279	0 Participants	0 Participants
Number of Participants With Hematology Parameters Outside Normal Range MCH pg, Low, Week 8, n=281, 276	2 Participants	5 Participants
Number of Participants With Hematology Parameters Outside Normal Range MCH pg, High, Week 8, n=281, 276	0 Participants	0 Participants
Number of Participants With Hematology Parameters Outside Normal Range MCHC g/L, Low, Week 4, n=283, 279	3 Participants	3 Participants
Number of Participants With Hematology Parameters Outside Normal Range MCHC g/L, High, Week 4, n=283, 279	19 Participants	17 Participants
Number of Participants With Hematology Parameters Outside Normal Range MCHC g/L, Low, Week 8, n=281, 276	3 Participants	7 Participants
Number of Participants With Hematology Parameters Outside Normal Range MCHC g/L, High, Week 8, n=281, 276	16 Participants	12 Participants
Number of Participants With Hematology Parameters Outside Normal Range MCV femtoliters (fL), Low, Week 4, n=283, 279	2 Participants	2 Participants
Number of Participants With Hematology Parameters Outside Normal Range MCV fL, High, Week 4, n=283, 279	0 Participants	1 Participants
Number of Participants With Hematology Parameters Outside Normal Range MCV fL, High, Week 8, n=281, 276	0 Participants	0 Participants
Number of Participants With Hematology Parameters Outside Normal Range Monocytes 10^9/L , Low, Week 4, n=282, 278	0 Participants	0 Participants
Number of Participants With Hematology Parameters Outside Normal Range Monocytes 10^9/L, High, Week 4, n=282, 278	3 Participants	2 Participants
Number of Participants With Hematology Parameters Outside Normal Range Monocytes 10^9/L, Low, Week 8, n=281, 276	0 Participants	0 Participants
Number of Participants With Hematology Parameters Outside Normal Range Monocytes 10^9/L, High, Week 8, n=281, 276	0 Participants	1 Participants
Number of Participants With Hematology Parameters Outside Normal Range Neutrophils 10^9/L, Low, Week 4, n=283, 279	7 Participants	8 Participants
Number of Participants With Hematology Parameters Outside Normal Range Neutrophils 10^9/L, High, Week 4, n=283, 279	3 Participants	2 Participants
Number of Participants With Hematology Parameters Outside Normal Range Neutrophils 10^9/L, Low, Week 8, n=281, 276	5 Participants	6 Participants
Number of Participants With Hematology Parameters Outside Normal Range Neutrophils 10^9/L, High, Week 8, n=281, 276	1 Participants	6 Participants
Number of Participants With Hematology Parameters Outside Normal Range Erythrocytes 10^12/L, Low, Week 4, n=283, 279	6 Participants	4 Participants
Number of Participants With Hematology Parameters Outside Normal Range Erythrocytes 10^12/L, High, Week 4, n=283, 279	4 Participants	7 Participants
Number of Participants With Hematology Parameters Outside Normal Range Erythrocytes 10^12/L, Low, Week 8, n=281, 276	2 Participants	8 Participants
Number of Participants With Hematology Parameters Outside Normal Range Erythrocytes 10^12/L, High, Week 8, n=281, 276	6 Participants	3 Participants
Number of Participants With Hematology Parameters Outside Normal Range Leukocytes 10^9/L, Low, Week 4, n=283, 279	15 Participants	12 Participants
Number of Participants With Hematology Parameters Outside Normal Range Leukocytes 10^9/L, High, Week 4, n=283, 279	2 Participants	2 Participants
Number of Participants With Hematology Parameters Outside Normal Range Leukocytes 10^9/L, Low, Week 8, n=281, 276	6 Participants	10 Participants
Number of Participants With Hematology Parameters Outside Normal Range Leukocytes 10^9/L, High, Week 8, n=281, 276	1 Participants	5 Participants
Number of Participants With Hematology Parameters Outside Normal Range Reticulocytes 10^12/L, Low, Week 4, n=283, 279	1 Participants	0 Participants
Number of Participants With Hematology Parameters Outside Normal Range Reticulocytes 10^12/L, High, Week 4, n=283, 279	1 Participants	3 Participants
Number of Participants With Hematology Parameters Outside Normal Range Reticulocytes 10^12/L, Low, Week 8, n=281, 276	1 Participants	1 Participants
Number of Participants With Hematology Parameters Outside Normal Range Reticulocytes 10^12/L, High, Week 8, n=281, 276	5 Participants	3 Participants
Number of Participants With Hematology Parameters Outside Normal Range Platelet 10^9/L, Low, Week 4, n=282, 279	6 Participants	4 Participants
Number of Participants With Hematology Parameters Outside Normal Range Platelet 10^9/L, High, Week 4, n=282, 279	0 Participants	0 Participants
Number of Participants With Hematology Parameters Outside Normal Range Platelet 10^9/L, Low, Week 8, n=280, 276	4 Participants	4 Participants
Number of Participants With Hematology Parameters Outside Normal Range Platelet 10^9/L, High, Week 8, n=280, 276	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 57

Population: Safety Population.

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.

Outcome measures

Outcome measures
Measure	AVA Alone n=286 Participants Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29	AVA+Raxibacumab n=280 Participants 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.
Number of Participants With Clinical Chemistry Parameters Outside Normal Range ALP U/L, Low, Week 8, n=282, 275	2 Participants	2 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range ALP U/L, High, Week 8, n=282, 275	13 Participants	19 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range ALT U/L, Low, Week 4, n=283, 279	45 Participants	44 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range ALT U/L, High, Week 4, n=283, 279	7 Participants	4 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Albumin g/L, Low, Week 4, n=283, 279	6 Participants	2 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Albumin g/L, High, Week 4, n=283, 279	1 Participants	0 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Albumin g/L, Low, Week 8, n=282, 275	2 Participants	1 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Albumin g/L, High, Week 8, n=282, 275	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range ALP units/liter (U/L), Low, Week 4, n=283, 279	3 Participants	5 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range ALP U/L, High, Week 4, n=283, 279	14 Participants	20 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range ALT U/L, Low, Week 8, n=282, 275	39 Participants	42 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range ALT U/L, High, Week 8, n=282, 275	7 Participants	6 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range AST U/L, Low, Week 4, n=283, 279	41 Participants	37 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range AST U/L, High, Week 4, n=283, 279	7 Participants	5 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range AST U/L, Low, Week 8, n=282, 275	38 Participants	34 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range AST U/L, High, Week 8, n=282, 275	6 Participants	10 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range D.bili micromole/Liter (µmol/L) LowWeek4,n=274,263	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range D.bili µmol/L, High, Week 4, n=274, 263	5 Participants	3 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range D.bili µmol/L, Low, Week 8, n=274, 261	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range D.bili µmol/L, High, Week 8, n=274, 261	5 Participants	9 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Bili µmol/L, Low, Week 4, n=280, 279	5 Participants	4 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Bili µmol/L, High, Week 4, n=280, 279	1 Participants	5 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Bili µmol/L, Low, Week 8, n=280, 273	3 Participants	2 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Bili µmol/L, High, Week 8, n=280, 273	2 Participants	7 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Cal,millimole/Liter (mmol/L)Low,Week 4,n=283, 279	6 Participants	4 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Cal mmol/L, High, Week 4, n=283, 279	2 Participants	4 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Cal mmol/L, Low, Week 8, n=282, 275	12 Participants	10 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Cal mmol/L, High, Week 8, n=282, 275	0 Participants	3 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Chloride mmol/L, Low, Week 4, n=283, 279	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Chloride mmol/L, High, Week 4, n=283, 279	19 Participants	12 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Chloride mmol/L, Low, Week 8, n=282, 275	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Chloride mmol/L, High, Week 8, n=282, 275	12 Participants	9 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range CO2 mmol/L, Low, Week 4, n=283, 279	7 Participants	11 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range CO2 mmol/L, High, Week 4, n=283, 279	14 Participants	12 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range CO2 mmol/L, Low, Week 8, n=282, 275	6 Participants	14 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range CO2 mmol/L, High, Week 8, n=282, 275	10 Participants	9 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Creatinine µmol/L, Low, Week 4, n=283, 279	19 Participants	10 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Creatinine µmol/L, High, Week 4, n=283, 279	6 Participants	3 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Creatinine µmol/L, Low, Week 8, n=282, 275	20 Participants	10 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Creatinine µmol/L, High, Week 8, n=282, 275	7 Participants	5 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range GGT U/L, Low, Week 4, n=283, 279	8 Participants	3 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range GGT U/L, High, Week 4, n=283, 279	4 Participants	3 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range GGT U/L, Low, Week 8, n=282, 275	10 Participants	6 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range GGT U/L, High, Week 8, n=282, 275	4 Participants	9 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Glucose mmol/L, Low, Week 4, n=283, 279	17 Participants	14 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Glucose mmol/L, High, Week 4, n=283, 279	16 Participants	31 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Glucose mmol/L, Low, Week 8, n=282, 275	16 Participants	16 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Glucose mmol/L, High, Week 8, n=282, 275	21 Participants	12 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Potassium mmol/L, Low, Week 4, n=283, 279	3 Participants	2 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Potassium mmol/L, High, Week 4, n=283, 279	1 Participants	1 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Potassium mmol/L, Low, Week 8, n=282, 275	1 Participants	2 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Potassium mmol/L, High, Week 8, n=282, 275	2 Participants	1 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Magnesium mmol/L, Low, Week 4, n=283, 279	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Magnesium mmol/L, High, Week 4, n=283, 279	0 Participants	2 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Magnesium mmol/L, Low, Week 8, n=282, 275	0 Participants	1 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Magnesium mmol/L, High, Week 8, n=282, 275	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Protein g/L, Low, Week 4, n=283, 279	16 Participants	17 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Protein g/L, High, Week 4, n=283, 279	1 Participants	2 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Protein g/L, Low, Week 8, n=282, 275	16 Participants	9 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Protein g/L, High, Week 8, n=282, 275	4 Participants	2 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Sodium mmol/L, Low, Week 4, n=283, 279	3 Participants	6 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Sodium mmol/L, High, Week 4, n=283, 279	1 Participants	1 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Sodium mmol/L, Low, Week 8, n=282, 275	5 Participants	6 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Sodium mmol/L, High, Week 8, n=282, 275	2 Participants	1 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Urate µmol/L, Low, Week 4, n=283, 279	5 Participants	5 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Urate µmol/L, High, Week 4, n=283, 279	4 Participants	5 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Urate µmol/L, Low, Week 8, n=282, 275	9 Participants	7 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range Urate µmol/L, High, Week 8, n=282, 275	4 Participants	4 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range UN mmol/L, Low, Week 4, n=283, 279	3 Participants	4 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range UN mmol/L, High, Week 4, n=283, 279	9 Participants	7 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range UN mmol/L, Low, Week 8, n=282, 275	3 Participants	6 Participants
Number of Participants With Clinical Chemistry Parameters Outside Normal Range UN mmol/L, High, Week 8, n=282, 275	8 Participants	7 Participants

SECONDARY outcome

Timeframe: Day 57

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	AVA Alone n=286 Participants Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29	AVA+Raxibacumab n=280 Participants 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.
Number of Participants With Urinalysis Parameters Hemoglobin +++	1 Participants	2 Participants
Number of Participants With Urinalysis Parameters Amorphous crystals 1+	1 Participants	5 Participants
Number of Participants With Urinalysis Parameters Amorphous crystals 2+	7 Participants	1 Participants
Number of Participants With Urinalysis Parameters Amorphous crystals 3+	0 Participants	3 Participants
Number of Participants With Urinalysis Parameters Amorphous crystals 4+	3 Participants	4 Participants
Number of Participants With Urinalysis Parameters Amorphous crystals trace	1 Participants	2 Participants
Number of Participants With Urinalysis Parameters Bacteria 1+	1 Participants	2 Participants
Number of Participants With Urinalysis Parameters Bacteria 2+	2 Participants	1 Participants
Number of Participants With Urinalysis Parameters Bacteria 3+	0 Participants	1 Participants
Number of Participants With Urinalysis Parameters Bacteria 4+	1 Participants	0 Participants
Number of Participants With Urinalysis Parameters Bacteria few	2 Participants	1 Participants
Number of Participants With Urinalysis Parameters Bacteria many	1 Participants	0 Participants
Number of Participants With Urinalysis Parameters Bacteria mod	1 Participants	2 Participants
Number of Participants With Urinalysis Parameters Bacteria Occ	3 Participants	7 Participants
Number of Participants With Urinalysis Parameters Bacteria rare	5 Participants	8 Participants
Number of Participants With Urinalysis Parameters Bacteria trace	2 Participants	3 Participants
Number of Participants With Urinalysis Parameters Bilirubin 1+	2 Participants	3 Participants
Number of Participants With Urinalysis Parameters Bilirubin negative	196 Participants	188 Participants
Number of Participants With Urinalysis Parameters Bilirubin small	0 Participants	2 Participants
Number of Participants With Urinalysis Parameters Ca Ox Crystals few	0 Participants	2 Participants
Number of Participants With Urinalysis Parameters Ca Ox Crystals rare	2 Participants	3 Participants
Number of Participants With Urinalysis Parameters Choriogonadotropin Beta negative	24 Participants	16 Participants
Number of Participants With Urinalysis Parameters Choriogonadotropin Beta positive	1 Participants	0 Participants
Number of Participants With Urinalysis Parameters Clarity, clear	38 Participants	44 Participants
Number of Participants With Urinalysis Parameters Clarity, cloudy	8 Participants	2 Participants
Number of Participants With Urinalysis Parameters Clarity turbid	1 Participants	0 Participants
Number of Participants With Urinalysis Parameters Color amber	2 Participants	5 Participants
Number of Participants With Urinalysis Parameters Color colorless	1 Participants	1 Participants
Number of Participants With Urinalysis Parameters Color light-red	0 Participants	1 Participants
Number of Participants With Urinalysis Parameters Color light-yellow	6 Participants	2 Participants
Number of Participants With Urinalysis Parameters Color yellow	74 Participants	71 Participants
Number of Participants With Urinalysis Parameters Crystals Ca-Ox	9 Participants	17 Participants
Number of Participants With Urinalysis Parameters Erythrocytes 0-2	107 Participants	104 Participants
Number of Participants With Urinalysis Parameters Erythrocytes 10-25	3 Participants	0 Participants
Number of Participants With Urinalysis Parameters Erythrocytes 2-5	2 Participants	6 Participants
Number of Participants With Urinalysis Parameters Erythrocytes 25-50	0 Participants	1 Participants
Number of Participants With Urinalysis Parameters Erythrocytes 5-10	1 Participants	2 Participants
Number of Participants With Urinalysis Parameters Erythrocytes 50-99	1 Participants	0 Participants
Number of Participants With Urinalysis Parameters Erythrocytes innumerable	0 Participants	1 Participants
Number of Participants With Urinalysis Parameters Erythrocytes less than 1	10 Participants	4 Participants
Number of Participants With Urinalysis Parameters Erythrocytes Tntc	1 Participants	0 Participants
Number of Participants With Urinalysis Parameters Glucose positive	1 Participants	0 Participants
Number of Participants With Urinalysis Parameters Glucose negative	257 Participants	257 Participants
Number of Participants With Urinalysis Parameters Hemoglobin +	13 Participants	18 Participants
Number of Participants With Urinalysis Parameters Hemoglobin ++	0 Participants	3 Participants
Number of Participants With Urinalysis Parameters Hemoglobin large	4 Participants	2 Participants
Number of Participants With Urinalysis Parameters Hemoglobin mod	3 Participants	6 Participants
Number of Participants With Urinalysis Parameters Hemoglobin negative	174 Participants	166 Participants
Number of Participants With Urinalysis Parameters Hemoglobin small	13 Participants	13 Participants
Number of Participants With Urinalysis Parameters Hemoglobin trace	2 Participants	1 Participants
Number of Participants With Urinalysis Parameters Ketone bodies negative	114 Participants	106 Participants
Number of Participants With Urinalysis Parameters Ketone bodies trace	0 Participants	4 Participants
Number of Participants With Urinalysis Parameters Ketones +	1 Participants	1 Participants
Number of Participants With Urinalysis Parameters Ketones ++	1 Participants	0 Participants
Number of Participants With Urinalysis Parameters Ketones ++++	0 Participants	2 Participants
Number of Participants With Urinalysis Parameters Ketones mod	1 Participants	0 Participants
Number of Participants With Urinalysis Parameters Ketones negative	255 Participants	247 Participants
Number of Participants With Urinalysis Parameters Ketones trace	0 Participants	7 Participants
Number of Participants With Urinalysis Parameters Leukocyte Cell Clumps Occ	1 Participants	0 Participants
Number of Participants With Urinalysis Parameters Leukocyte Cell Clumps rare	1 Participants	1 Participants
Number of Participants With Urinalysis Parameters Leukocyte Esterase 1+	4 Participants	2 Participants
Number of Participants With Urinalysis Parameters Leukocyte Esterase 2+	1 Participants	1 Participants
Number of Participants With Urinalysis Parameters Leukocyte Esterase 3+	1 Participants	0 Participants
Number of Participants With Urinalysis Parameters Leukocyte Esterase large	10 Participants	7 Participants
Number of Participants With Urinalysis Parameters Leukocyte Esterase Mod	1 Participants	3 Participants
Number of Participants With Urinalysis Parameters Leukocyte Esterase Moderate	1 Participants	4 Participants
Number of Participants With Urinalysis Parameters Leukocyte Esterase negative	162 Participants	159 Participants
Number of Participants With Urinalysis Parameters Leukocyte Esterase small	5 Participants	7 Participants
Number of Participants With Urinalysis Parameters Leukocyte Esterase trace	13 Participants	10 Participants
Number of Participants With Urinalysis Parameters Leukocyte +	5 Participants	0 Participants
Number of Participants With Urinalysis Parameters Leukocyte ++	1 Participants	0 Participants
Number of Participants With Urinalysis Parameters Leukocyte +++	1 Participants	1 Participants
Number of Participants With Urinalysis Parameters Leukocyte 0-2	105 Participants	99 Participants
Number of Participants With Urinalysis Parameters Leukocyte 10-25	2 Participants	2 Participants
Number of Participants With Urinalysis Parameters Leukocyte 2-5	6 Participants	7 Participants
Number of Participants With Urinalysis Parameters Leukocyte 25-50	0 Participants	1 Participants
Number of Participants With Urinalysis Parameters Leukocyte 5-10	2 Participants	4 Participants
Number of Participants With Urinalysis Parameters Leukocyte less than 1	8 Participants	5 Participants
Number of Participants With Urinalysis Parameters Leukocyte large	4 Participants	5 Participants
Number of Participants With Urinalysis Parameters Leukocyte mod	1 Participants	5 Participants
Number of Participants With Urinalysis Parameters Leukocyte negative	187 Participants	188 Participants
Number of Participants With Urinalysis Parameters Leukocyte small	2 Participants	5 Participants
Number of Participants With Urinalysis Parameters Leukocyte trace	9 Participants	7 Participants
Number of Participants With Urinalysis Parameters Mucous threads 2+	0 Participants	1 Participants
Number of Participants With Urinalysis Parameters Mucous Threads few	24 Participants	25 Participants
Number of Participants With Urinalysis Parameters Mucous Threads many	2 Participants	1 Participants
Number of Participants With Urinalysis Parameters Mucous Threads Mod	1 Participants	2 Participants
Number of Participants With Urinalysis Parameters Mucous Threads trace	1 Participants	2 Participants
Number of Participants With Urinalysis Parameters Nitrite negative	190 Participants	190 Participants
Number of Participants With Urinalysis Parameters Nitrite positive	8 Participants	3 Participants
Number of Participants With Urinalysis Parameters Occult Blood 1+	1 Participants	0 Participants
Number of Participants With Urinalysis Parameters Occult Blood 2+	1 Participants	2 Participants
Number of Participants With Urinalysis Parameters Occult Blood 3+	0 Participants	1 Participants
Number of Participants With Urinalysis Parameters Occult Blood large	5 Participants	3 Participants
Number of Participants With Urinalysis Parameters Occult Blood mod	1 Participants	5 Participants
Number of Participants With Urinalysis Parameters Occult Blood moderate	2 Participants	7 Participants
Number of Participants With Urinalysis Parameters Occult Blood negative	163 Participants	148 Participants
Number of Participants With Urinalysis Parameters Occult Blood small	22 Participants	21 Participants
Number of Participants With Urinalysis Parameters Occult Blood trace	3 Participants	6 Participants
Number of Participants With Urinalysis Parameters Protein +	7 Participants	10 Participants
Number of Participants With Urinalysis Parameters Protein ++	2 Participants	0 Participants
Number of Participants With Urinalysis Parameters Protein ++++	0 Participants	1 Participants
Number of Participants With Urinalysis Parameters Protein 1+	3 Participants	4 Participants
Number of Participants With Urinalysis Parameters Protein large	1 Participants	0 Participants
Number of Participants With Urinalysis Parameters Protein negative	244 Participants	238 Participants
Number of Participants With Urinalysis Parameters Protein non-heam	1 Participants	0 Participants
Number of Participants With Urinalysis Parameters Protein trace	12 Participants	15 Participants
Number of Participants With Urinalysis Parameters Specific Gravity <=1.005	1 Participants	5 Participants
Number of Participants With Urinalysis Parameters Specific Gravity >=1.030	3 Participants	6 Participants
Number of Participants With Urinalysis Parameters Squamous Epithelial Cells 0-2	8 Participants	3 Participants
Number of Participants With Urinalysis Parameters Squamous Epithelial Cells 2-5	2 Participants	5 Participants
Number of Participants With Urinalysis Parameters Squamous Epithelial Cells 5-10	2 Participants	2 Participants
Number of Participants With Urinalysis Parameters Squamous Epithelial Cells <1	9 Participants	8 Participants
Number of Participants With Urinalysis Parameters Turbidity clear	15 Participants	15 Participants
Number of Participants With Urinalysis Parameters Turbidity cloudy	2 Participants	3 Participants
Number of Participants With Urinalysis Parameters Turbidity hazy	19 Participants	16 Participants
Number of Participants With Urinalysis Parameters Urobilinogen <2.0	113 Participants	111 Participants
Number of Participants With Urinalysis Parameters Urobilinogen less than 2.0	33 Participants	31 Participants
Number of Participants With Urinalysis Parameters Urobilinogen normal	47 Participants	46 Participants
Number of Participants With Urinalysis Parameters Transitional Epithelial Cells <1	2 Participants	0 Participants

Adverse Events

AVA Alone

Serious events: 5 serious events

Other events: 85 other events

Deaths: 1 deaths

Raxibacumab Only and Discontinued Due to AE During Raxibacumab Infusion

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

AVA + Raxibacumab With no AE During Raxibacumab Infusion That Led to Discontinuation

Serious events: 3 serious events

Other events: 80 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	AVA Alone n=286 participants at risk Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29	Raxibacumab Only and Discontinued Due to AE During Raxibacumab Infusion n=6 participants at risk During the study, six of 286 raxibacumab-treated subjects (2.1%) had adverse events (AEs) to raxibacumab that required drug discontinuation, administration of additional medications for mitigation of signs and symptoms, and discontinuation from the study. This new arm is included to capture safety data for these 6 subjects.	AVA + Raxibacumab With no AE During Raxibacumab Infusion That Led to Discontinuation n=280 participants at risk 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.
Hepatobiliary disorders Bile Duct Stone	0.00% 0/286 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population	0.00% 0/6 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population	0.36% 1/280 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population
Hepatobiliary disorders Cholecystitis	0.00% 0/286 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population	0.00% 0/6 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population	0.36% 1/280 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population
Hepatobiliary disorders Cholelithiasis	0.00% 0/286 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population	0.00% 0/6 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population	0.36% 1/280 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population
Infections and infestations Bronchitis	0.00% 0/286 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population	0.00% 0/6 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population	0.36% 1/280 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population
Injury, poisoning and procedural complications Toxicity To Various Agents	0.35% 1/286 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population	0.00% 0/6 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population	0.00% 0/280 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.35% 1/286 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population	0.00% 0/6 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population	0.00% 0/280 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population
Pregnancy, puerperium and perinatal conditions Abortion Spontaneous	0.70% 2/286 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population	0.00% 0/6 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population	0.00% 0/280 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population
Psychiatric disorders Completed Suicide	0.00% 0/286 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population	0.00% 0/6 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population	0.36% 1/280 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population
Psychiatric disorders Suicidal Ideation	0.35% 1/286 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population	0.00% 0/6 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population	0.00% 0/280 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population
Respiratory, thoracic and mediastinal disorders Asphyxia	0.00% 0/286 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population	0.00% 0/6 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population	0.36% 1/280 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/286 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population	0.00% 0/6 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population	0.36% 1/280 • On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183. Safety Population

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER