Therapeutic Treatment of Inhalation Anthrax
Conditions
Keywords
Monoclonal Antibody, Safety, Raxibacumab, HGS1021, Immunogenicity
Brief summary
This is an open-label study to evaluate the immunogenicity and safety of raxibacumab in healthy adult male and female subjects. Subjects who have received raxibacumab \>= 4 months ago will be enrolled and dosed as follows: A maximum of 25 subjects (to include 3 evaluable female subjects) will receive a second dose of raxibacumab equal to that of the previous dose \>= 4 months following the first dose. Subjects will remain in house from Day 0 until Day 1 and will be followed for 70 days after receiving the second dose of raxibacumab. Raxibacumab has been shown to provide improved survival in rabbit and monkey anthrax spore challenge studies. Preliminary data from our rabbit pivotal efficacy study showed significant survival benefit for raxibacumab over placebo. Exposure to anthrax and resulting clinical disease can occur more than once, especially in individuals who do not develop protective immunity. Hence, if clinically indicated for the treatment of anthrax, there may be a requirement for the repeat administration of raxibacumab. The rationale of the study is to evaluate the immunogenicity and safety of repeat administration of raxibacumab with a \>= 4 month interval between dosing.
Interventions
BIOLOGICALRaxibacumab
Raxibacumab will be supplied in 50 milliliter (mL) sterile, single-use vials containing 34.9 mL of liquid formulation per vial. Each vial contains 50 milligram (mg)/mL raxibacumab in 0.13 mg/mL citric acid, 2.8 mg/mL sodium citrate, 10 mg/mL sucrose, 18 mg/mL glycine, 0.2 mg/mL polysorbate 80, pH 6.5
Sponsors
GlaxoSmithKline
Emergent BioSolutions
Human Genome Sciences Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Enrolled and treated with raxibacumab in another HGS protocol, \>= 4 months ago. * Male or female \>= 18 and \<= 64 years of age. * Laboratory values that are Grade 0 by the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables. Subjects with laboratory values that are Grade 1 and are not considered clinically significant by the Principal Investigator may be enrolled following consultation with the Medical Monitor. * A female subject is eligible to enter the study if she is: Not pregnant or nursing, Post menopausal, has had a hysterectomy, or documentation of sterility, Of child bearing potential (ie, woman with an intact uterus and ovaries and no documentation of oviductal or uterine dysfunction that would cause sterility). * These women must have a negative blood pregnancy test at screening and on Day -1 prior to dosing and agree to 1 of the following: a)Complete abstinence from intercourse from the date of screening through the duration of follow-up, b)Consistent and correct use of 1 of the following medically accepted methods of birth control, in addition to a male partner who correctly uses a condom or is sterile prior to the female subject's entry into the study and is the sole sexual partner for the female subject from the date of screening through the duration of follow-up, implants of levonorgestrel; injectable progesterone; any intrauterine device (IUD) with a documented failure rate of less than 1% per year; oral contraceptives (either combined or progesterone only); double barrier method: condom, cervical cap or diaphragm with spermicidal agent; transdermal contraceptive patch. * All males who are not sterile must agree to either abstain from intercourse or consistently and correctly use a condom while their female partner agrees to use 1 of the appropriate medically accepted methods of birth control listed above from the date of screening through the duration of follow-up. * Have the ability to understand the requirements of the study, provide written informed consent (including consent for the use and disclosure of research-related health information), comply with the study protocol procedures, and agree to return for the required study visits.
Exclusion criteria
* History or clinical evidence of significant, acute, or chronic diseases (ie, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological, or infectious diseases), which could confound the results of the study or put the subject at undue risk. * Prior immunization with anthrax vaccine adsorbed (AVA), prior treatment with investigational anthrax therapies (other than raxibacumab \>= 4 months ago), prior treatment for anthrax exposure, or a confirmed anthrax infection. * History of Type I hypersensitivity reaction to food or drugs, intravenous (IV) contrast dye, or history of urticaria. * Previous hypersensitivity to raxibacumab. * Previous serious or Grade 3 or greater raxibacumab related adverse event (AE). * Drug or alcohol addiction within the last 12 months. Subjects who have documented addiction free period of at least 12 months and in the clinical judgement of the investigator are not at risk for relapse may be enrolled in the study. * Evidence of active or suspected malignancy or history of malignancy 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 in any other clinical trials of an investigational compound within 60 days of initiating study agent or refusal to refrain from participation during this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Developed a Positive Anti-raxibacumab Antibody Response | From the date of the dose administration of study agent for this study (Day 0) until Day 70 | Number of participants who developed an positive anti-raxibacumab antibody response during the study were assessed.The antibody response to raxibacumab was assessed using a screening assay (i.e. by electrochemiluminescence counts). Positive samples would be further tested in an inhibition of binding assay to confirm the specificity of binding. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hematological Toxicities of the Indicated Grade | From the date of the dose administration of study agent for this study (Day 0) until Day 70 | 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 date of the dose administration of study agent for this study (Day 0) until Day 70 | The number of participants with at least a 2-grade worsening from Baseline in hematological toxicities is presented. 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 date of the dose administration of study agent for this study (Day 0) until Day 70 | 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 date of the dose administration of study agent for this study (Day 0) until Day 70 | The number of participants with at least a 2-grade worsening from Baseline in liver toxicities is presented. 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 date of the dose administration of study agent for this study (Day 0) until Day 70 | 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 Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | From the date of the dose administration of study agent for this study (Day 0) until Day 70 | 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 Other Chemistry Toxicities of the Indicated Grade | From the date of the dose administration of study agent for this study (Day 0) until Day 70 | 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 date of the dose administration of study agent for this study (Day 0) until Day 70 | The number of participants with at least a 2-grade worsening from Baseline in other chemistry toxicities is presented. 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 Urinalysis Toxicities of the Indicated Grade | From the date of the dose administration of study agent for this study (Day 0) until Day 70 | 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 date of the dose administration of study agent for this study (Day 0) until Day 70 | 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. |
| Mean Raxibacumab Concentration-time Following an IV Infusion Raxibacumab Dose | From the date of the dose administration of study agent for this study (Day 0) until Day 56 | Blood was collected from each participant at the selected times: pre-dose (Day 0), 0.00347 hours (Day 0), 0.3333 hours (Day 0), Day 1, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42, and Day 56 post-dose. 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 |
| Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | From the date of the dose administration of study agent for this study (Day 0) until Day 70 | The number of participants with at least a 2-grade worsening from Baseline in electrolyte toxicities is presented. 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. |
Participant flow
Recruitment details
Participants who had received raxibacumab \>= 4 months in another HGS study (study # HGS1021-C1064) prior to this study were eligible for enrollment in this study.
Participants by arm
| Arm | Count |
|---|---|
| Raxibacumab Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Raxibacumab |
|---|---|
| Age, Continuous | 40.6 Years STANDARD_DEVIATION 13.3 |
| Race/Ethnicity, Customized Black or African American | 7 Participants |
| Race/Ethnicity, Customized White | 13 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Number of Participants Who Developed a Positive Anti-raxibacumab Antibody Response
Number of participants who developed an positive anti-raxibacumab antibody response during the study were assessed.The antibody response to raxibacumab was assessed using a screening assay (i.e. by electrochemiluminescence counts). Positive samples would be further tested in an inhibition of binding assay to confirm the specificity of binding.
Time frame: From the date of the dose administration of study agent for this study (Day 0) until Day 70
Population: As-treated population : all participants who received 1 dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Raxibacumab | Number of Participants Who Developed a Positive Anti-raxibacumab Antibody Response | 0 Participants |
Secondary
Mean Raxibacumab Concentration-time Following an IV Infusion Raxibacumab Dose
Blood was collected from each participant at the selected times: pre-dose (Day 0), 0.00347 hours (Day 0), 0.3333 hours (Day 0), Day 1, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42, and Day 56 post-dose. 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
Time frame: From the date of the dose administration of study agent for this study (Day 0) until Day 56
Population: As-treated population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Raxibacumab | Mean Raxibacumab Concentration-time Following an IV Infusion Raxibacumab Dose | Pre-dose | 1.358 Micrograms/milliliter (µg/mL) | Standard Deviation 1.879 |
| Raxibacumab | Mean Raxibacumab Concentration-time Following an IV Infusion Raxibacumab Dose | 0.00347 hr | 979.078 Micrograms/milliliter (µg/mL) | Standard Deviation 147.543 |
| Raxibacumab | Mean Raxibacumab Concentration-time Following an IV Infusion Raxibacumab Dose | 0.3333 hr | 865.874 Micrograms/milliliter (µg/mL) | Standard Deviation 122.602 |
| Raxibacumab | Mean Raxibacumab Concentration-time Following an IV Infusion Raxibacumab Dose | Day 1 | 784.122 Micrograms/milliliter (µg/mL) | Standard Deviation 118.68 |
| Raxibacumab | Mean Raxibacumab Concentration-time Following an IV Infusion Raxibacumab Dose | Day 3 | 580.068 Micrograms/milliliter (µg/mL) | Standard Deviation 94.776 |
| Raxibacumab | Mean Raxibacumab Concentration-time Following an IV Infusion Raxibacumab Dose | Day 7 | 418.253 Micrograms/milliliter (µg/mL) | Standard Deviation 62.35 |
| Raxibacumab | Mean Raxibacumab Concentration-time Following an IV Infusion Raxibacumab Dose | Day 14 | 300.589 Micrograms/milliliter (µg/mL) | Standard Deviation 41.689 |
| Raxibacumab | Mean Raxibacumab Concentration-time Following an IV Infusion Raxibacumab Dose | Day 21 | 238.190 Micrograms/milliliter (µg/mL) | Standard Deviation 39.515 |
| Raxibacumab | Mean Raxibacumab Concentration-time Following an IV Infusion Raxibacumab Dose | Day 28 | 208.646 Micrograms/milliliter (µg/mL) | Standard Deviation 44.802 |
| Raxibacumab | Mean Raxibacumab Concentration-time Following an IV Infusion Raxibacumab Dose | Day 42 | 131.473 Micrograms/milliliter (µg/mL) | Standard Deviation 44.308 |
| Raxibacumab | Mean Raxibacumab Concentration-time Following an IV Infusion Raxibacumab Dose | Day 56 | 96.932 Micrograms/milliliter (µg/mL) | Standard Deviation 46.637 |
Secondary
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 date of the dose administration of study agent for this study (Day 0) until Day 70
Population: As-treated population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Raxibacumab | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any AE | 8 Participants |
| Raxibacumab | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any SAE | 0 Participants |
Secondary
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 is presented. 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 date of the dose administration of study agent for this study (Day 0) until Day 70
Population: As-treated population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypernatremia, any>=2-grade worsening | 0 Participants |
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hyponatremia, any>=2-grade worsening | 0 Participants |
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hyperkalemia, any>=2-grade worsening | 0 Participants |
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypokalemia, any>=2-grade worsening | 0 Participants |
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypomagnesemia, any>=2-grade worsening | 0 Participants |
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypercalcemia, any>=2-grade worsening | 0 Participants |
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypocalcemia, any>=2-grade worsening | 0 Participants |
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities | Hypophosphatemia, any>=2-grade worsening | 0 Participants |
Secondary
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 is presented. 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 date of the dose administration of study agent for this study (Day 0) until Day 70
Population: As-treated population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Leukocytosis, any>=2-grade worsening | 0 Participants |
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Leukopenia, any >=2-grade worsening | 0 Participants |
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Lymphopenia, any>=2-grade worsening | 1 Participants |
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Neutropenia, any >=2-grade worsening | 0 Participants |
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Hemoglobin, any>=2-grade worsening | 0 Participants |
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Platelet, any>=2-grade worsening | 0 Participants |
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Prothrombin Time, any >=2-grade worsening | 1 Participants |
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities | Partial Thromboplastin Time, any>=2grade worsening | 1 Participants |
Secondary
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 is presented. 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 date of the dose administration of study agent for this study (Day 0) until Day 70
Population: As-treated population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities | AST, any>=2-grade worsening | 0 Participants |
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities | ALT, any>=2-grade worsening | 1 Participants |
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities | GGT, any>=2-grade worsening | 0 Participants |
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities | Alkaline phosphatase, any>=2-grade worsening | 0 Participants |
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities | Hyperbilirubinemia, any>=2-grade worsening | 0 Participants |
Secondary
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 is presented. 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 date of the dose administration of study agent for this study (Day 0) until Day 70
Population: As-treated population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Creatinine, any>=2-grade worsening | 0 Participants |
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Hypoalbuminemia, any>=2-grade worsening | 0 Participants |
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Hyperuricemia, any>=2-grade worsening | 0 Participants |
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Hyperglycemia, any>=2-grade worsening | 1 Participants |
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Hypoglycemia, any>=2-grade worsening | 0 Participants |
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities | Amylase, any>=2-grade worsening | 0 Participants |
Secondary
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 date of the dose administration of study agent for this study (Day 0) until Day 70
Population: As-treated population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Raxibacumab | Number of Participants With at Least a 2-grade Worsening From Baseline in Urinalysis Toxicities | 0 Participants |
Secondary
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 date of the dose administration of study agent for this study (Day 0) until Day 70
Population: As-treated population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyponatremia, Grade 1 | 2 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypomagnesemia, Grade 4 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypernatremia, Grade 1 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypernatremia, Grade 2 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypernatremia, Grade 3 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypernatremia, Grade 4 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyponatremia, Grade 2 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyponatremia, Grade 3 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyponatremia, Grade 4 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyperkalemia, Grade 1 | 1 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyperkalemia, Grade 2 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyperkalemia, Grade 3 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hyperkalemia, Grade 4 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypokalemia, Grade 1 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypokalemia, Grade 2 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypokalemia, Grade 3 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypokalemia, Grade 4 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypomagnesemia, Grade 1 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypomagnesemia, Grade 2 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypomagnesemia, Grade 3 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypercalcemia, Grade 1 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypercalcemia, Grade 2 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypercalcemia, Grade 3 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypercalcemia, Grade 4 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypocalcemia, Grade 1 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypocalcemia, Grade 2 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypocalcemia, Grade 3 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypocalcemia, Grade 4 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypophosphatemia, Grade 1 | 1 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypophosphatemia, Grade 2 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypophosphatemia, Grade 3 | 0 Participants |
| Raxibacumab | Number of Participants With Electrolyte Toxicities of the Indicated Grade | Hypophosphatemia, Grade 4 | 0 Participants |
Secondary
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 date of the dose administration of study agent for this study (Day 0) until Day 70
Population: As-treated population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukocytosis, Grade 1 | 0 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukocytosis, Grade 2 | 0 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukocytosis, Grade 3 | 0 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukocytosis, Grade 4 | 0 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukopenia, Grade 1 | 5 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukopenia, Grade 2 | 0 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukopenia, Grade 3 | 0 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Leukopenia, Grade 4 | 0 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Lymphopenia, Grade 1 | 0 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Lymphopenia, Grade 2 | 1 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Lymphopenia, Grade 3 | 0 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Lymphopenia, Grade 4 | 0 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Neutropenia, Grade 1 | 2 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Neutropenia, Grade 2 | 0 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Neutropenia, Grade 3 | 0 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Neutropenia, Grade 4 | 0 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Hemoglobin, Grade 1 | 1 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Hemoglobin, Grade 2 | 0 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Hemoglobin, Grade 3 | 0 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Hemoglobin, Grade 4 | 0 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Platelet, Grade 1 | 0 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Platelet, Grade 2 | 0 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Platelet, Grade 3 | 0 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Platelet, Grade 4 | 0 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Prothrombin Time, Grade 1 | 0 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Prothrombin Time, Grade 2 | 0 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Prothrombin Time, Grade 3 | 0 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Prothrombin Time, Grade 4 | 1 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Partial Thromboplastin Time, Grade 1 | 0 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Partial Thromboplastin Time, Grade 2 | 1 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Partial Thromboplastin Time, Grade 3 | 0 Participants |
| Raxibacumab | Number of Participants With Hematological Toxicities of the Indicated Grade | Partial Thromboplastin Time, Grade 4 | 0 Participants |
Secondary
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 date of the dose administration of study agent for this study (Day 0) until Day 70
Population: As-treated population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Raxibacumab | Number of Participants With Liver Toxicities of the Indicated Grade | Alkaline Phosphatase, Grade 4 | 0 Participants |
| Raxibacumab | Number of Participants With Liver Toxicities of the Indicated Grade | Aspartate amino transferase (AST), Grade 1 | 2 Participants |
| Raxibacumab | Number of Participants With Liver Toxicities of the Indicated Grade | AST, Grade 2 | 0 Participants |
| Raxibacumab | Number of Participants With Liver Toxicities of the Indicated Grade | AST, Grade 3 | 0 Participants |
| Raxibacumab | Number of Participants With Liver Toxicities of the Indicated Grade | AST, Grade 4 | 0 Participants |
| Raxibacumab | Number of Participants With Liver Toxicities of the Indicated Grade | Alanine amino transferase(ALT), Grade 1 | 1 Participants |
| Raxibacumab | Number of Participants With Liver Toxicities of the Indicated Grade | ALT, Grade 2 | 1 Participants |
| Raxibacumab | Number of Participants With Liver Toxicities of the Indicated Grade | ALT, Grade 3 | 0 Participants |
| Raxibacumab | Number of Participants With Liver Toxicities of the Indicated Grade | ALT, Grade 4 | 0 Participants |
| Raxibacumab | Number of Participants With Liver Toxicities of the Indicated Grade | Gamma-glutayl-transferase (GGT), Grade 1 | 0 Participants |
| Raxibacumab | Number of Participants With Liver Toxicities of the Indicated Grade | GGT, Grade 2 | 0 Participants |
| Raxibacumab | Number of Participants With Liver Toxicities of the Indicated Grade | GGT, Grade 3 | 0 Participants |
| Raxibacumab | Number of Participants With Liver Toxicities of the Indicated Grade | GGT, Grade 4 | 0 Participants |
| Raxibacumab | Number of Participants With Liver Toxicities of the Indicated Grade | Alkaline Phosphatase, Grade 1 | 0 Participants |
| Raxibacumab | Number of Participants With Liver Toxicities of the Indicated Grade | Alkaline Phosphatase, Grade 2 | 0 Participants |
| Raxibacumab | Number of Participants With Liver Toxicities of the Indicated Grade | Alkaline Phosphatase, Grade 3 | 0 Participants |
| Raxibacumab | Number of Participants With Liver Toxicities of the Indicated Grade | Hyperbilirubinemia, Grade 1 | 0 Participants |
| Raxibacumab | Number of Participants With Liver Toxicities of the Indicated Grade | Hyperbilirubinemia, Grade 2 | 0 Participants |
| Raxibacumab | Number of Participants With Liver Toxicities of the Indicated Grade | Hyperbilirubinemia, Grade 3 | 0 Participants |
| Raxibacumab | Number of Participants With Liver Toxicities of the Indicated Grade | Hyperbilirubinemia, Grade 4 | 0 Participants |
Secondary
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 date of the dose administration of study agent for this study (Day 0) until Day 70
Population: As-treated population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Raxibacumab | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Creatinine, Grade 1 | 0 Participants |
| Raxibacumab | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Creatinine, Grade 2 | 0 Participants |
| Raxibacumab | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Creatinine, Grade 3 | 0 Participants |
| Raxibacumab | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Creatinine, Grade 4 | 0 Participants |
| Raxibacumab | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoalbuminemia, Grade 1 | 0 Participants |
| Raxibacumab | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoalbuminemia, Grade 2 | 0 Participants |
| Raxibacumab | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoalbuminemia, Grade 3 | 0 Participants |
| Raxibacumab | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoalbuminemia, Grade 4 | 0 Participants |
| Raxibacumab | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperuricemia, Grade 1 | 1 Participants |
| Raxibacumab | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperuricemia, Grade 2 | 0 Participants |
| Raxibacumab | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperuricemia, Grade 3 | 0 Participants |
| Raxibacumab | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperuricemia, Grade 4 | 0 Participants |
| Raxibacumab | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperglycemia, Grade 1 | 4 Participants |
| Raxibacumab | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperglycemia, Grade 2 | 1 Participants |
| Raxibacumab | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperglycemia, Grade 3 | 0 Participants |
| Raxibacumab | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hyperglycemia, Grade 4 | 0 Participants |
| Raxibacumab | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoglycemia, Grade 1 | 2 Participants |
| Raxibacumab | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoglycemia, Grade 2 | 0 Participants |
| Raxibacumab | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoglycemia, Grade 3 | 0 Participants |
| Raxibacumab | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Hypoglycemia, Grade 4 | 0 Participants |
| Raxibacumab | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Amylase, Grade 1 | 3 Participants |
| Raxibacumab | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Amylase, Grade 2 | 1 Participants |
| Raxibacumab | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Amylase, Grade 3 | 0 Participants |
| Raxibacumab | Number of Participants With Other Chemistry Toxicities of the Indicated Grade | Amylase, Grade 4 | 0 Participants |
Secondary
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 date of the dose administration of study agent for this study (Day 0) until Day 70
Population: As-treated population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Raxibacumab | Number of Participants With Urinalysis Toxicities of the Indicated Grade | 0 Participants |