Healthy
Conditions
Keywords
healthy volunteers
Brief summary
To evaluate the safety and tolerability of raxibacumab in healthy subjects.
Interventions
DRUGplacebo
40 mg/kg intravenously, double dose (day 0 and 14), Group 3
DRUGraxibacumab
40 mg/kg intravenously, double dose (day 0 and 14), Group 1
Sponsors
GlaxoSmithKline
Emergent BioSolutions
Human Genome Sciences Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Male or female, 18 years of age or older * Normal laboratory (blood test) results * Subjects are eligible to enter the study if they are not pregnant or nursing, are sterile or of non-childbearing potential, or are willing to practice abstinence or use appropriate birth control methods during the study (about 2 months) Key
Exclusion criteria
* History of significant, acute or chronic diseases (ie, heart, lung, gastrointestinal, liver, kidney, neurological or infectious diseases). * Prior immunization with anthrax vaccine adsorbed (AVA), prior treatment with investigational anthrax therapies, prior treatment for anthrax exposure, or prior anthrax infection. * History of Type I hypersensitivity reaction to food or drugs, IV contrast agents, antihistamines, or history of hives. * A current drug or alcohol addiction. * Positive for human immunodeficiency virus (HIV-1), Hepatitis B surface antigen, or Hepatitis C antibody. * Cancer within the last 5 years (with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix). * Participation within 60 days of intiating study or refusal to refrain from participation during the study in any other clinical trials of an investigational compound. * Previous exposure to raxibacumab.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Developed an Anti-raxibacumab Antibody Response | From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose) | Number of participants who developed an anti-raxibacumab antibody response during the study were assessed. .Immunogenicity testing was performed to determine if raxibacumab induced an anti-raxibacumab immune response. Testing comprised of 2 assays (screening and confirmatory). The screening assay (direct binding) was an electrochemiluminescence (ECL)-based bridging assay. A rabbit polyclonal antibody was used as a positive control. Samples above the assay cut point were considered positive. Samples identified as positive in the screening assay were confirmed positive in a confirmatory assay. Samples must have demonstrated a significant percent drop in the confirmatory inhibition of binding assay to be considered positive. The inhibition of binding confirmatory assay was performed identically to the direct binding screening assay with the exception that the samples were tested in parallel with excess unlabeled raxibacumab. |
| Number of Participants With Urinalysis Toxicities of the Indicated Grade | From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose) | Urinaysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. |
| Number of Participants With at Least a 2-grade Worsening From Baseline in Urinalysis Toxicities | From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose) | Urinalysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing. |
| Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose) | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. This includes worsening (eg, increase in frequency or severity) of pre-existing conditions. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs. |
| Number of Participants With Hematological Toxicities of the Indicated Grade | From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose) | Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. |
| Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose) | The number of participants with at least a 2-grade worsening from Baseline in hematological toxicities were assessed. Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing. |
| Number of Participants With Liver Toxicities of the Indicated Grade | From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose) | Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. |
| Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities | From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose) | The number of participants with at least a 2-grade worsening from Baseline in liver toxicities were assessed. Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing. |
| Number of Participants With Electrolyte Toxicities of the Indicated Grade | From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose) | Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. |
| Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose) | The number of participants with at least a 2-grade worsening from Baseline in electrolyte toxicities were assessed. Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing. |
| Number of Participants With Other Chemistry Toxicities of the Indicated Grade | From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose) | Other chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. |
| Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose) | The number of participants with at least a 2-grade worsening from Baseline in other chemistry toxicities were assessed. Other clinical chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing. |
| Number of Participants With Thyroid Toxicities of the Indicated Grade | From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose) | Clinical thyroid parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Raxibacumab Concentration-time Following Two IV Infusion Doses | Pre-dose on Days 0 and 14, at 30 minutes and 2 to 6 hours after completion of each raxibacumab infusion, and at 28, 42, 56, and 70 days after the 1st raxibacumab dose | Blood was collected from each participant at selected times post dose, and serum specimens were analyzed for raxibacumab using a validated electrochemiluminescense-based assay. The individual serum raxibacumab concentration data were summarized by nominal collection time and treatment group using descriptive statistics. For the participants that received two doses, blood samples for serum raxibacumab concentration measurement were collected from participants prior to administration of the raxibacumab and diphenhydramine doses on Days 0 and 14, at 30 minutes and 2 to 6 hours after completion of each raxibacumab infusion, and at 28, 42, 56, and 70 days after the 1st raxibacumab dose. |
| Mean Raxibacumab Concentration-time Following a Single IV Infusion Dose | Pre-dose on Day 0, at 30 minutes and 2 to 6 hours after completion of raxibacumab infusion, and at 14, 28, and 56 days after the raxibacumab dose | Blood was collected from each participant at selected times post dose, and serum specimens were analyzed for raxibacumab using a validated electrochemiluminescense-based assay. The individual serum raxibacumab concentration data were summarized by nominal collection time and treatment group using descriptive statistics. Blood samples for serum raxibacumab concentration measurement were collected from participants who received a single-dose prior to administration of the raxibacumab and diphenhydramine doses on Day 0, at 30 minutes and 2 to 6 hours after completion of the raxibacumab infusion, and at 14, 28, and 56 days after the raxibacumab dose. |
Participant flow
Recruitment details
Participants were randomized to a treatment group at a ratio of 3:1 (raxibacumab:placebo). Participants were randomized to the double dose cohorts first. When randomization was completed for the double-dose cohorts, participants were then randomized into the single-dose cohorts.
Pre-assignment details
A total of 322 participants were randomized and 320 participants were administered at least one dose of study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Placebo - Single-Dose Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams \[mg\]) up to 60 minutes prior to infusion of placebo. | 74 |
| Placebo - Double-Dose Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo. | 6 |
| Raxibacumab - Single-Dose Participants received a single dose of 40 mg/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab. | 217 |
| Raxibacumab - Double-Dose Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab. | 23 |
| Total | 320 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 0 |
| Overall Study | Lack of Compliance | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 6 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 | 4 | 0 |
Baseline characteristics
| Characteristic | Placebo - Single-Dose | Placebo - Double-Dose | Raxibacumab - Single-Dose | Raxibacumab - Double-Dose | Total |
|---|---|---|---|---|---|
| Age, Continuous | 39.8 Years STANDARD_DEVIATION 16.8 | 52.2 Years STANDARD_DEVIATION 13.8 | 40.3 Years STANDARD_DEVIATION 16.3 | 48.5 Years STANDARD_DEVIATION 14.6 | 41.0 Years STANDARD_DEVIATION 16.4 |
| Race/Ethnicity, Customized Asian | 4 Participants | 0 Participants | 15 Participants | 0 Participants | 19 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 2 Participants | 21 Participants | 1 Participants | 28 Participants |
| Race/Ethnicity, Customized Hispanic or Latino origin | 7 Participants | 0 Participants | 28 Participants | 1 Participants | 36 Participants |
| Race/Ethnicity, Customized Multiracial | 2 Participants | 0 Participants | 7 Participants | 0 Participants | 9 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Not Listed | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 57 Participants | 4 Participants | 143 Participants | 21 Participants | 225 Participants |
| Sex: Female, Male Female | 30 Participants | 4 Participants | 117 Participants | 13 Participants | 164 Participants |
| Sex: Female, Male Male | 44 Participants | 2 Participants | 100 Participants | 10 Participants | 156 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 32 / 74 | 6 / 6 | 103 / 217 | 10 / 23 |
| serious Total, serious adverse events | 0 / 74 | 1 / 6 | 0 / 217 | 1 / 23 |
Outcome results
Primary
Number of Participants Who Developed an Anti-raxibacumab Antibody Response
Number of participants who developed an anti-raxibacumab antibody response during the study were assessed. .Immunogenicity testing was performed to determine if raxibacumab induced an anti-raxibacumab immune response. Testing comprised of 2 assays (screening and confirmatory). The screening assay (direct binding) was an electrochemiluminescence (ECL)-based bridging assay. A rabbit polyclonal antibody was used as a positive control. Samples above the assay cut point were considered positive. Samples identified as positive in the screening assay were confirmed positive in a confirmatory assay. Samples must have demonstrated a significant percent drop in the confirmatory inhibition of binding assay to be considered positive. The inhibition of binding confirmatory assay was performed identically to the direct binding screening assay with the exception that the samples were tested in parallel with excess unlabeled raxibacumab.
Time frame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)
Population: As-treated population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo - Single-Dose | Number of Participants Who Developed an Anti-raxibacumab Antibody Response | 0 Participants |
| Placebo - Double-Dose | Number of Participants Who Developed an Anti-raxibacumab Antibody Response | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants Who Developed an Anti-raxibacumab Antibody Response | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants Who Developed an Anti-raxibacumab Antibody Response | 0 Participants |
Primary
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. This includes worsening (eg, increase in frequency or severity) of pre-existing conditions. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.
Time frame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)
Population: As-treated population: all participants who received at least one dose of study agent, with the assignment to treatment based on the actual treatment received, unless otherwise specified
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo - Single-Dose | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any AE | 32 Participants |
| Placebo - Single-Dose | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any SAE | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any SAE | 1 Participants |
| Placebo - Double-Dose | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any AE | 6 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any AE | 103 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any SAE | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any AE | 10 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any SAE | 1 Participants |
Primary
Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities
The number of participants with at least a 2-grade worsening from Baseline in electrolyte toxicities were assessed. Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.
Time frame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)
Population: As-treated population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypernatremia, any >=2-grade worsening | 0 Participants |
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hyponatremia, any >=2-grade worsening | 0 Participants |
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hyperkalemia, any >=2-grade worsening | 0 Participants |
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypokalemia, any >=2-grade worsening | 0 Participants |
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypomagnesemia, any >=2-grade worsening | 0 Participants |
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | HrC/adjusted for albumin, any >=2-grade worsening | 0 Participants |
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | HoC/adjusted for albumin, any >=2-grade worsening | 0 Participants |
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypercalcemia/unadjusted, any >=2-grade worsening | 0 Participants |
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypocalcemia/unadjusted, any >=2-grade worsening | 0 Participants |
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypophosphatemia, any >=2-grade worsening | 1 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hyperkalemia, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypocalcemia/unadjusted, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypokalemia, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypomagnesemia, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | HrC/adjusted for albumin, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | HoC/adjusted for albumin, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypophosphatemia, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypercalcemia/unadjusted, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypernatremia, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hyponatremia, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypercalcemia/unadjusted, any >=2-grade worsening | 1 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | HoC/adjusted for albumin, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypophosphatemia, any >=2-grade worsening | 5 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypernatremia, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypokalemia, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | HrC/adjusted for albumin, any >=2-grade worsening | 1 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypocalcemia/unadjusted, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hyponatremia, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypomagnesemia, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hyperkalemia, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypomagnesemia, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypercalcemia/unadjusted, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | HrC/adjusted for albumin, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypophosphatemia, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | HoC/adjusted for albumin, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hyponatremia, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hyperkalemia, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypokalemia, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypernatremia, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypocalcemia/unadjusted, any >=2-grade worsening | 0 Participants |
Primary
Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities
The number of participants with at least a 2-grade worsening from Baseline in hematological toxicities were assessed. Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.
Time frame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)
Population: As-treated population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Leukocytosis, any >=2-grade worsening | 1 Participants |
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Leukopenia, any >=2-grade worsening | 0 Participants |
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Neutropenia, any >=2-grade worsening | 1 Participants |
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Lymphopenia, any >=2-grade worsening | 0 Participants |
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Hemoglobin, any >=2-grade worsening | 0 Participants |
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Platelet, any >=2-grade worsening | 0 Participants |
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Prothrombin Time, any >=2-grade worsening | 0 Participants |
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Activated PTT, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Platelet, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Hemoglobin, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Leukopenia, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Activated PTT, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Prothrombin Time, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Lymphopenia, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Neutropenia, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Leukocytosis, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Prothrombin Time, any >=2-grade worsening | 2 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Neutropenia, any >=2-grade worsening | 2 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Lymphopenia, any >=2-grade worsening | 1 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Hemoglobin, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Platelet, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Activated PTT, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Leukocytosis, any >=2-grade worsening | 2 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Leukopenia, any >=2-grade worsening | 1 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Neutropenia, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Lymphopenia, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Leukopenia, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Leukocytosis, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Hemoglobin, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Activated PTT, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Prothrombin Time, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Platelet, any >=2-grade worsening | 0 Participants |
Primary
Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities
The number of participants with at least a 2-grade worsening from Baseline in liver toxicities were assessed. Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.
Time frame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)
Population: As-treated population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities | ALP, any >=2-grade worsening | 0 Participants |
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities | ALT, any >=2-grade worsening | 0 Participants |
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities | Hyperbilirubinemia, any >=2-grade worsening | 0 Participants |
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities | GGT, any >=2-grade worsening | 0 Participants |
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities | AST, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities | GGT, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities | ALP, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities | Hyperbilirubinemia, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities | ALT, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities | AST, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities | GGT, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities | AST, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities | ALT, any >=2-grade worsening | 1 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities | ALP, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities | Hyperbilirubinemia, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities | ALP, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities | ALT, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities | AST, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities | GGT, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities | Hyperbilirubinemia, any >=2-grade worsening | 0 Participants |
Primary
Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities
The number of participants with at least a 2-grade worsening from Baseline in other chemistry toxicities were assessed. Other clinical chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.
Time frame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)
Population: As-treated population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Creatinine, any >=2-grade worsening | 0 Participants |
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Hypoglycemia, any >=2-grade worsening | 2 Participants |
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Hyperglycemia, any >=2-grade worsening | 0 Participants |
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | BUN, any >=2-grade worsening | 0 Participants |
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Amylase, any >=2-grade worsening | 3 Participants |
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Hypoalbuminemia, any >=2-grade worsening | 0 Participants |
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Hyperuricemia, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Hypoglycemia, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Hyperuricemia, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Hypoalbuminemia, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Hyperglycemia, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Amylase, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | BUN, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Creatinine, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Hyperuricemia, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Creatinine, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | BUN, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Hypoalbuminemia, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Hyperglycemia, any >=2-grade worsening | 1 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Hypoglycemia, any >=2-grade worsening | 2 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Amylase, any >=2-grade worsening | 3 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Hypoalbuminemia, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Amylase, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Hypoglycemia, any >=2-grade worsening | 3 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | BUN, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Creatinine, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Hyperglycemia, any >=2-grade worsening | 1 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Hyperuricemia, any >=2-grade worsening | 0 Participants |
Primary
Number of Participants With at Least a 2-grade Worsening From Baseline in Urinalysis Toxicities
Urinalysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.
Time frame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)
Population: As-treated population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Urinalysis Toxicities | Proteinuria, any >=2-grade worsening | 3 Participants |
| Placebo - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Urinalysis Toxicities | Hematuria, any >=2-grade worsening | 4 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Urinalysis Toxicities | Hematuria, any >=2-grade worsening | 0 Participants |
| Placebo - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Urinalysis Toxicities | Proteinuria, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Urinalysis Toxicities | Proteinuria, any >=2-grade worsening | 8 Participants |
| Raxibacumab - Single-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Urinalysis Toxicities | Hematuria, any >=2-grade worsening | 12 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Urinalysis Toxicities | Proteinuria, any >=2-grade worsening | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With at Least a 2-grade Worsening From Baseline in Urinalysis Toxicities | Hematuria, any >=2-grade worsening | 2 Participants |
Primary
Number of Participants With Electrolyte Toxicities of the Indicated Grade
Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.
Time frame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)
Population: As-treated population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypophosphatemia, Grade 2 | 1 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyperkalemia, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | HoC adjusted for albumin, Grade 2 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypercalcemia/ unadjusted, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypernatremia, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyperkalemia, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | HrC/ adjusted for albumin, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypocalcemia/ unadjusted, Grade 2 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypernatremia, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypokalemia, Grade 1 | 5 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | HoC/ adjusted for albumin, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypocalcemia/ unadjusted, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | HrC/ adjusted for albumin, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypokalemia, Grade 2 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypophosphatemia, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypophosphatemia, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | HoC/ adjusted for albumin, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypokalemia, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyponatremia, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypercalcemia/ unadjusted, Grade 1 | 2 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypernatremia, Grade 2 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypokalemia, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyponatremia, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypocalcemia/ unadjusted, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyponatremia, Grade 1 | 8 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypomagnesemia, Grade 1 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypocalcemia (HoC)/ adjusted for albumin, Grade 1 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypocalcemia/ unadjusted, Grade 1 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | HrC/ adjusted for albumin, Grade 2 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypomagnesemia, Grade 2 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypercalcemia/ unadjusted, Grade 2 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyperkalemia, Grade 1 | 3 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyperkalemia, Grade 2 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypomagnesemia, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypercalcemia (HrC)/ adjusted for albumin, Grade 1 | 2 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypophosphatemia, Grade 1 | 3 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypernatremia, Grade 1 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypomagnesemia, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypercalcemia/ unadjusted, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyponatremia, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypophosphatemia, Grade 1 | 1 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypercalcemia (HrC)/ adjusted for albumin, Grade 1 | 1 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyponatremia, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | HrC/ adjusted for albumin, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyperkalemia, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypophosphatemia, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | HrC/ adjusted for albumin, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypocalcemia/ unadjusted, Grade 1 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | HrC/ adjusted for albumin, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypocalcemia (HoC)/ adjusted for albumin, Grade 1 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypophosphatemia, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyponatremia, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | HoC adjusted for albumin, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyperkalemia, Grade 1 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | HoC/ adjusted for albumin, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypophosphatemia, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypercalcemia/ unadjusted, Grade 1 | 1 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypocalcemia/ unadjusted, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyponatremia, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypercalcemia/ unadjusted, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | HoC/ adjusted for albumin, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyperkalemia, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypernatremia, Grade 1 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyperkalemia, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypercalcemia/ unadjusted, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypokalemia, Grade 1 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypernatremia, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypokalemia, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypocalcemia/ unadjusted, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypercalcemia/ unadjusted, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypokalemia, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypernatremia, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypokalemia, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypomagnesemia, Grade 1 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypocalcemia/ unadjusted, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyponatremia, Grade 1 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypomagnesemia, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypomagnesemia, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypernatremia, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypomagnesemia, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyponatremia, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypercalcemia/ unadjusted, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypercalcemia/ unadjusted, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypocalcemia/ unadjusted, Grade 1 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypocalcemia/ unadjusted, Grade 2 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyperkalemia, Grade 1 | 3 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypocalcemia/ unadjusted, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypocalcemia/ unadjusted, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypophosphatemia, Grade 1 | 10 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypophosphatemia, Grade 2 | 5 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyperkalemia, Grade 2 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypophosphatemia, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypernatremia, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypophosphatemia, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyperkalemia, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyperkalemia, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypokalemia, Grade 1 | 12 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypokalemia, Grade 2 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypernatremia, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypokalemia, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypokalemia, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypomagnesemia, Grade 1 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypomagnesemia, Grade 2 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyponatremia, Grade 1 | 20 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypomagnesemia, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypomagnesemia, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypercalcemia (HrC)/ adjusted for albumin, Grade 1 | 5 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | HrC/ adjusted for albumin, Grade 2 | 1 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyponatremia, Grade 2 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | HoC/ adjusted for albumin, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | HrC/ adjusted for albumin, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypernatremia, Grade 2 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | HrC/ adjusted for albumin, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypocalcemia (HoC)/ adjusted for albumin, Grade 1 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | HoC adjusted for albumin, Grade 2 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyponatremia, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | HoC/ adjusted for albumin, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypernatremia, Grade 1 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypercalcemia/ unadjusted, Grade 1 | 4 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypercalcemia/ unadjusted, Grade 2 | 1 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypophosphatemia, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypernatremia, Grade 1 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypernatremia, Grade 2 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypernatremia, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypernatremia, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyponatremia, Grade 1 | 5 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyponatremia, Grade 2 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyponatremia, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyponatremia, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyperkalemia, Grade 1 | 3 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyperkalemia, Grade 2 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyperkalemia, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyperkalemia, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypokalemia, Grade 1 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypokalemia, Grade 2 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypokalemia, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypokalemia, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypomagnesemia, Grade 1 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypomagnesemia, Grade 2 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypomagnesemia, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypomagnesemia, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypercalcemia (HrC)/ adjusted for albumin, Grade 1 | 3 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | HrC/ adjusted for albumin, Grade 2 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | HrC/ adjusted for albumin, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | HrC/ adjusted for albumin, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypocalcemia (HoC)/ adjusted for albumin, Grade 1 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | HoC adjusted for albumin, Grade 2 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | HoC/ adjusted for albumin, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | HoC/ adjusted for albumin, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypercalcemia/ unadjusted, Grade 1 | 2 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypercalcemia/ unadjusted, Grade 2 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypercalcemia/ unadjusted, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypercalcemia/ unadjusted, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypocalcemia/ unadjusted, Grade 1 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypocalcemia/ unadjusted, Grade 2 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypocalcemia/ unadjusted, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypocalcemia/ unadjusted, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypophosphatemia, Grade 1 | 3 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypophosphatemia, Grade 2 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypophosphatemia, Grade 3 | 0 Participants |
Primary
Number of Participants With Hematological Toxicities of the Indicated Grade
Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.
Time frame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)
Population: As-treated population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Neutropenia, Grade 1 | 4 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukocytosis, Grade 2 | 1 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukocytosis, Grade 3 | 1 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukocytosis, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukopenia, Grade 1 | 9 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukopenia, Grade 2 | 1 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukopenia, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukopenia, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukocytosis, Grade 1 | 4 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Neutropenia, Grade 2 | 1 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Neutropenia, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Neutropenia, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Lymphopenia, Grade 1 | 1 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Lymphopenia, Grade 2 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Lymphopenia, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Lymphopenia, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Hemoglobin, Grade 1 | 1 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Hemoglobin, Grade 2 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Hemoglobin, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Hemoglobin, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Platelet, Grade 1 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Platelet, Grade 2 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Platelet, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Platelet, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Prothrombin Time, Grade 1 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Prothrombin Time, Grade 2 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Prothrombin Time, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Prothrombin Time, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Activated PartialThromboplastinTime(PTT) , Grade 1 | 3 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Activated PTT, Grade 2 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Activated PTT, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Activated PTT, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Prothrombin Time, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Hemoglobin, Grade 1 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukocytosis, Grade 1 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Neutropenia, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Activated PartialThromboplastinTime(PTT) , Grade 1 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Hemoglobin, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Prothrombin Time, Grade 1 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Prothrombin Time, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukopenia, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Hemoglobin, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukocytosis, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Neutropenia, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Lymphopenia, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Hemoglobin, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukocytosis, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Lymphopenia, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Activated PTT, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Platelet, Grade 1 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukopenia, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Lymphopenia, Grade 1 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Activated PTT, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Platelet, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukocytosis, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Neutropenia, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Neutropenia, Grade 1 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Platelet, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukopenia, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Activated PTT, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Prothrombin Time, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Platelet, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukopenia, Grade 1 | 1 Participants |
| Placebo - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Lymphopenia, Grade 2 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Activated PartialThromboplastinTime(PTT) , Grade 1 | 10 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukocytosis, Grade 1 | 15 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Lymphopenia, Grade 2 | 1 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukocytosis, Grade 2 | 2 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Prothrombin Time, Grade 3 | 2 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Prothrombin Time, Grade 1 | 2 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukocytosis, Grade 3 | 1 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Prothrombin Time, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Lymphopenia, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukocytosis, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukopenia, Grade 1 | 25 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Neutropenia, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukopenia, Grade 2 | 6 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Prothrombin Time, Grade 2 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukopenia, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Lymphopenia, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukopenia, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Activated PTT, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Hemoglobin, Grade 1 | 12 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Hemoglobin, Grade 2 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Neutropenia, Grade 4 | 1 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Activated PTT, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Hemoglobin, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Neutropenia, Grade 2 | 1 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Hemoglobin, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Platelet, Grade 1 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Platelet, Grade 2 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Lymphopenia, Grade 1 | 3 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Activated PTT, Grade 2 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Platelet, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Neutropenia, Grade 1 | 8 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Platelet, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukopenia, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Neutropenia, Grade 1 | 1 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Neutropenia, Grade 2 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Neutropenia, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Prothrombin Time, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Neutropenia, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Activated PTT, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Lymphopenia, Grade 1 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Lymphopenia, Grade 2 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Lymphopenia, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Prothrombin Time, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Lymphopenia, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Activated PTT, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Hemoglobin, Grade 1 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Hemoglobin, Grade 2 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Hemoglobin, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Activated PartialThromboplastinTime(PTT) , Grade 1 | 1 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Hemoglobin, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Platelet, Grade 1 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Platelet, Grade 2 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Platelet, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Activated PTT, Grade 2 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Platelet, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukocytosis, Grade 1 | 2 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukocytosis, Grade 2 | 2 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukocytosis, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Prothrombin Time, Grade 1 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukocytosis, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukopenia, Grade 1 | 4 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukopenia, Grade 2 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukopenia, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Hematological Toxicities of the Indicated Grade | Prothrombin Time, Grade 2 | 0 Participants |
Primary
Number of Participants With Liver Toxicities of the Indicated Grade
Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.
Time frame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)
Population: As-treated population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | ALP, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | GGT, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | AST, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | ALP, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Alkaline Phosphatase(ALP), Grade 1 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Aspartate amino transferase (AST), Grade 1 | 2 Participants |
| Placebo - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | ALP, Grade 2 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | AST, Grade 2 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Hyperbilirubinemia, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Alanine amino transferase(ALT), Grade 1 | 1 Participants |
| Placebo - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | ALT, Grade 2 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Hyperbilirubinemia, Grade 2 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | ALT, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Hyperbilirubinemia, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | ALT, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | AST, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Hyperbilirubinemia, Grade 1 | 3 Participants |
| Placebo - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Gamma-glutamyl-transferase (GGT), Grade 1 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | GGT, Grade 2 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | GGT, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | ALP, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | GGT, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Hyperbilirubinemia, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | ALP, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | ALT, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | GGT, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Aspartate amino transferase (AST), Grade 1 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Hyperbilirubinemia, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | GGT, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Alkaline Phosphatase(ALP), Grade 1 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | ALT, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | ALP, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Gamma-glutamyl-transferase (GGT), Grade 1 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | AST, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Hyperbilirubinemia, Grade 1 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | AST, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | ALT, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Alanine amino transferase(ALT), Grade 1 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | AST, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Hyperbilirubinemia, Grade 2 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Alkaline Phosphatase(ALP), Grade 1 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Aspartate amino transferase (AST), Grade 1 | 7 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | AST, Grade 2 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | AST, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | AST, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Alanine amino transferase(ALT), Grade 1 | 6 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | ALT, Grade 2 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | ALT, Grade 3 | 1 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | ALT, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Gamma-glutamyl-transferase (GGT), Grade 1 | 3 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | GGT, Grade 2 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | GGT, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | GGT, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | ALP, Grade 2 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | ALP, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | ALP, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Hyperbilirubinemia, Grade 1 | 5 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Hyperbilirubinemia, Grade 2 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Hyperbilirubinemia, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Hyperbilirubinemia, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | GGT, Grade 2 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Gamma-glutamyl-transferase (GGT), Grade 1 | 1 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Hyperbilirubinemia, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | ALP, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | ALT, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | ALT, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | AST, Grade 2 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Hyperbilirubinemia, Grade 1 | 1 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | ALT, Grade 2 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Alanine amino transferase(ALT), Grade 1 | 1 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Aspartate amino transferase (AST), Grade 1 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Hyperbilirubinemia, Grade 2 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | AST, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Alkaline Phosphatase(ALP), Grade 1 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | AST, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | ALP, Grade 2 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | GGT, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | GGT, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | Hyperbilirubinemia, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Liver Toxicities of the Indicated Grade | ALP, Grade 3 | 0 Participants |
Primary
Number of Participants With Other Chemistry Toxicities of the Indicated Grade
Other chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.
Time frame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)
Population: As-treated population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperglycemia, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperglycemia, Grade 1 | 15 Participants |
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoalbuminemia, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoglycemia, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | BUN, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Creatinine, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | BUN, Grade 2 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoglycemia, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperglycemia, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Creatinine, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoalbuminemia, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Amylase, Grade 1 | 5 Participants |
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Creatinine, Grade 2 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperuricemia, Grade 1 | 1 Participants |
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoglycemia, Grade 1 | 5 Participants |
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Amylase, Grade 2 | 4 Participants |
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperglycemia, Grade 2 | 1 Participants |
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoalbuminemia, Grade 2 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Amylase, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | BUN, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperuricemia, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Blood Urea Nitrogen (BUN), Grade 1 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Amylase, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoglycemia, Grade 2 | 2 Participants |
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperuricemia, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoalbuminemia, Grade 1 | 3 Participants |
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Creatinine, Grade 1 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperuricemia, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Creatinine, Grade 1 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | BUN, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Creatinine, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Creatinine, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperglycemia, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | BUN, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Creatinine, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperuricemia, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Blood Urea Nitrogen (BUN), Grade 1 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperuricemia, Grade 1 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | BUN, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperglycemia, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Amylase, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoglycemia, Grade 1 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoalbuminemia, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoglycemia, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoglycemia, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperglycemia, Grade 1 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoalbuminemia, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoglycemia, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperuricemia, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Amylase, Grade 1 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperuricemia, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoalbuminemia, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Amylase, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperglycemia, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoalbuminemia, Grade 1 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Amylase, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Creatinine, Grade 1 | 2 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperuricemia, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperglycemia, Grade 1 | 36 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperglycemia, Grade 2 | 1 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperglycemia, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperglycemia, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoglycemia, Grade 1 | 11 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoglycemia, Grade 2 | 2 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoglycemia, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoglycemia, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Amylase, Grade 1 | 25 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Amylase, Grade 2 | 5 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Amylase, Grade 3 | 1 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Amylase, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperuricemia, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Creatinine, Grade 2 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Creatinine, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Creatinine, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Blood Urea Nitrogen (BUN), Grade 1 | 1 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | BUN, Grade 2 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | BUN, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | BUN, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoalbuminemia, Grade 1 | 1 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoalbuminemia, Grade 2 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoalbuminemia, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoalbuminemia, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperuricemia, Grade 1 | 8 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperuricemia, Grade 2 | 1 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperuricemia, Grade 1 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | BUN, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Amylase, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Amylase, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperglycemia, Grade 2 | 2 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoalbuminemia, Grade 1 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Amylase, Grade 2 | 1 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Amylase, Grade 1 | 2 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperglycemia, Grade 1 | 8 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoalbuminemia, Grade 2 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoglycemia, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoglycemia, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperuricemia, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoalbuminemia, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoglycemia, Grade 2 | 3 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoglycemia, Grade 1 | 2 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperuricemia, Grade 2 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoalbuminemia, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperglycemia, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Blood Urea Nitrogen (BUN), Grade 1 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperglycemia, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | BUN, Grade 2 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Creatinine, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Creatinine, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperuricemia, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | BUN, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Creatinine, Grade 2 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Creatinine, Grade 1 | 0 Participants |
Primary
Number of Participants With Thyroid Toxicities of the Indicated Grade
Clinical thyroid parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.
Time frame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)
Population: As-treated population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo - Single-Dose | Number of Participants With Thyroid Toxicities of the Indicated Grade | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Thyroid Toxicities of the Indicated Grade | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Thyroid Toxicities of the Indicated Grade | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Thyroid Toxicities of the Indicated Grade | 0 Participants |
Primary
Number of Participants With Urinalysis Toxicities of the Indicated Grade
Urinaysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.
Time frame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)
Population: As-treated population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo - Single-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Proteinuria, Grade 1 | 9 Participants |
| Placebo - Single-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Proteinuria, Grade 2 | 3 Participants |
| Placebo - Single-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Proteinuria, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Proteinuria, Grade 4 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Hematuria, Grade 1 | 9 Participants |
| Placebo - Single-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Hematuria, Grade 2 | 4 Participants |
| Placebo - Single-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Hematuria, Grade 3 | 0 Participants |
| Placebo - Single-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Hematuria, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Hematuria, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Hematuria, Grade 1 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Proteinuria, Grade 2 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Hematuria, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Hematuria, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Proteinuria, Grade 4 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Proteinuria, Grade 3 | 0 Participants |
| Placebo - Double-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Proteinuria, Grade 1 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Hematuria, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Proteinuria, Grade 3 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Proteinuria, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Hematuria, Grade 1 | 17 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Hematuria, Grade 2 | 15 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Hematuria, Grade 4 | 0 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Proteinuria, Grade 1 | 31 Participants |
| Raxibacumab - Single-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Proteinuria, Grade 2 | 9 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Proteinuria, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Proteinuria, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Proteinuria, Grade 2 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Proteinuria, Grade 1 | 3 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Hematuria, Grade 1 | 3 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Hematuria, Grade 4 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Hematuria, Grade 3 | 0 Participants |
| Raxibacumab - Double-Dose | Number of Participants With Urinalysis Toxicities of the Indicated Grade | Hematuria, Grade 2 | 2 Participants |
Secondary
Mean Raxibacumab Concentration-time Following a Single IV Infusion Dose
Blood was collected from each participant at selected times post dose, and serum specimens were analyzed for raxibacumab using a validated electrochemiluminescense-based assay. The individual serum raxibacumab concentration data were summarized by nominal collection time and treatment group using descriptive statistics. Blood samples for serum raxibacumab concentration measurement were collected from participants who received a single-dose prior to administration of the raxibacumab and diphenhydramine doses on Day 0, at 30 minutes and 2 to 6 hours after completion of the raxibacumab infusion, and at 14, 28, and 56 days after the raxibacumab dose.
Time frame: Pre-dose on Day 0, at 30 minutes and 2 to 6 hours after completion of raxibacumab infusion, and at 14, 28, and 56 days after the raxibacumab dose
Population: Pharmacokinetics (PK) Population: all evaluable participants who received a raxibacumab dose and had at least 1 measurable post-dose serum raxibacumab concentration.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo - Single-Dose | Mean Raxibacumab Concentration-time Following a Single IV Infusion Dose | Predose | 0.048 Micrograms per milliliter (μg/mL) | Standard Deviation 0.631 |
| Placebo - Single-Dose | Mean Raxibacumab Concentration-time Following a Single IV Infusion Dose | 30 minutes post-dose | 928.447 Micrograms per milliliter (μg/mL) | Standard Deviation 191.293 |
| Placebo - Single-Dose | Mean Raxibacumab Concentration-time Following a Single IV Infusion Dose | 2-6 hours post-dose | 881.586 Micrograms per milliliter (μg/mL) | Standard Deviation 192.676 |
| Placebo - Single-Dose | Mean Raxibacumab Concentration-time Following a Single IV Infusion Dose | Day 14 | 311.669 Micrograms per milliliter (μg/mL) | Standard Deviation 78.037 |
| Placebo - Single-Dose | Mean Raxibacumab Concentration-time Following a Single IV Infusion Dose | Day 28 | 199.043 Micrograms per milliliter (μg/mL) | Standard Deviation 43.812 |
| Placebo - Single-Dose | Mean Raxibacumab Concentration-time Following a Single IV Infusion Dose | Day 56 | 89.021 Micrograms per milliliter (μg/mL) | Standard Deviation 31.531 |
Secondary
Mean Raxibacumab Concentration-time Following Two IV Infusion Doses
Blood was collected from each participant at selected times post dose, and serum specimens were analyzed for raxibacumab using a validated electrochemiluminescense-based assay. The individual serum raxibacumab concentration data were summarized by nominal collection time and treatment group using descriptive statistics. For the participants that received two doses, blood samples for serum raxibacumab concentration measurement were collected from participants prior to administration of the raxibacumab and diphenhydramine doses on Days 0 and 14, at 30 minutes and 2 to 6 hours after completion of each raxibacumab infusion, and at 28, 42, 56, and 70 days after the 1st raxibacumab dose.
Time frame: Pre-dose on Days 0 and 14, at 30 minutes and 2 to 6 hours after completion of each raxibacumab infusion, and at 28, 42, 56, and 70 days after the 1st raxibacumab dose
Population: Pharmacokinetics (PK) Population: all evaluable participants who received a raxibacumab dose and had at least 1 measurable post-dose serum raxibacumab concentration.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo - Single-Dose | Mean Raxibacumab Concentration-time Following Two IV Infusion Doses | Dose 1 - Predose | 0 Micrograms per milliliter (μg/mL) | Standard Deviation 0 |
| Placebo - Single-Dose | Mean Raxibacumab Concentration-time Following Two IV Infusion Doses | Dose 1 - 30 minutes post-dose | 1012.564 Micrograms per milliliter (μg/mL) | Standard Deviation 243.662 |
| Placebo - Single-Dose | Mean Raxibacumab Concentration-time Following Two IV Infusion Doses | Dose 1 - 2-6 hours post-dose | 973.910 Micrograms per milliliter (μg/mL) | Standard Deviation 261.825 |
| Placebo - Single-Dose | Mean Raxibacumab Concentration-time Following Two IV Infusion Doses | Dose 2 - Predose | 314.374 Micrograms per milliliter (μg/mL) | Standard Deviation 55.297 |
| Placebo - Single-Dose | Mean Raxibacumab Concentration-time Following Two IV Infusion Doses | Dose 2 - 30 minutes post-dose | 1246.223 Micrograms per milliliter (μg/mL) | Standard Deviation 224.481 |
| Placebo - Single-Dose | Mean Raxibacumab Concentration-time Following Two IV Infusion Doses | Dose 2 - 2-6 hours post-dose | 1211.572 Micrograms per milliliter (μg/mL) | Standard Deviation 210.793 |
| Placebo - Single-Dose | Mean Raxibacumab Concentration-time Following Two IV Infusion Doses | Dose 2 - Day 14 | 543.767 Micrograms per milliliter (μg/mL) | Standard Deviation 125.511 |
| Placebo - Single-Dose | Mean Raxibacumab Concentration-time Following Two IV Infusion Doses | Dose 2 - Day 28 | 334.431 Micrograms per milliliter (μg/mL) | Standard Deviation 78.98 |
| Placebo - Single-Dose | Mean Raxibacumab Concentration-time Following Two IV Infusion Doses | Dose 2 - Day 42 | 213.463 Micrograms per milliliter (μg/mL) | Standard Deviation 61.553 |
| Placebo - Single-Dose | Mean Raxibacumab Concentration-time Following Two IV Infusion Doses | Dose 2 - Day 56 | 137.878 Micrograms per milliliter (μg/mL) | Standard Deviation 46.231 |