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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
| Emergent BioSolutions | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Raxibacumab arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raxibacumab | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the date of the dose administration of study agent for this study (Day 0) until Day 70 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | Human Genome Sciences Inc. | Study Director |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| HGS1021-C1069 | Clinical Study Report | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | As-treated population : all participants who received 1 dose of study treatment. | Posted | Number | Participants | From the date of the dose administration of study agent for this study (Day 0) until Day 70 |
|
Serious adverse events (SAEs) and non-serious AEs were collected from the time the first dose of study agent (Day 0) until Day 70.
SAEs and non-serious AEs were collected in the as-treated population, comprised of all participants randomized to treatment who received one dose of study agent.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MeDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | Human Genome Sciences Inc. | 866-435-7343 |
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| ID | Term |
|---|---|
| C542124 | raxibacumab |
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|
| From the date of the dose administration of study agent for this study (Day 0) until Day 70 |
| 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. | From the date of the dose administration of study agent for this study (Day 0) until Day 70 |
| 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. | From the date of the dose administration of study agent for this study (Day 0) until Day 70 |
| 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. | From the date of the dose administration of study agent for this study (Day 0) until Day 70 |
| 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. | From the date of the dose administration of study agent for this study (Day 0) until Day 70 |
| 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. | From the date of the dose administration of study agent for this study (Day 0) until Day 70 |
| 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. | From the date of the dose administration of study agent for this study (Day 0) until Day 70 |
| 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. | From the date of the dose administration of study agent for this study (Day 0) until Day 70 |
| 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. | From the date of the dose administration of study agent for this study (Day 0) until Day 70 |
| 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. | From the date of the dose administration of study agent for this study (Day 0) until Day 70 |
| 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. | From the date of the dose administration of study agent for this study (Day 0) until Day 70 |
| 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 | From the date of the dose administration of study agent for this study (Day 0) until Day 56 |
For additional information about this study please refer to the GSK Clinical Study Register |
| HGS1021-C1069 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HGS1021-C1069 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HGS1021-C1069 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HGS1021-C1069 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HGS1021-C1069 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HGS1021-C1069 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
|
|
| 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. | As-treated population | Posted | Number | Participants | From the date of the dose administration of study agent for this study (Day 0) until Day 70 |
|
|
|
| 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. | As-treated population | Posted | Number | Participants | From the date of the dose administration of study agent for this study (Day 0) until Day 70 |
|
|
|
| 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. | As-treated population | Posted | Number | Participants | From the date of the dose administration of study agent for this study (Day 0) until Day 70 |
|
|
|
| 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. | As-treated population | Posted | Number | Participants | From the date of the dose administration of study agent for this study (Day 0) until Day 70 |
|
|
|
| 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. | As-treated population | Posted | Number | Participants | From the date of the dose administration of study agent for this study (Day 0) until Day 70 |
|
|
|
| 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. | As-treated population | Posted | Number | Participants | From the date of the dose administration of study agent for this study (Day 0) until Day 70 |
|
|
|
| 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. | As-treated population | Posted | Number | Participants | From the date of the dose administration of study agent for this study (Day 0) until Day 70 |
|
|
|
| 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. | As-treated population | Posted | Number | Participants | From the date of the dose administration of study agent for this study (Day 0) until Day 70 |
|
|
|
| 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. | As-treated population | Posted | Number | Participants | From the date of the dose administration of study agent for this study (Day 0) until Day 70 |
|
|
|
| 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. | As-treated population | Posted | Number | Participants | From the date of the dose administration of study agent for this study (Day 0) until Day 70 |
|
|
|
| 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. | As-treated population | Posted | Number | Participants | From the date of the dose administration of study agent for this study (Day 0) until Day 70 |
|
|
|
| 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 | As-treated population | Posted | Mean | Standard Deviation | Micrograms/milliliter (µg/mL) | From the date of the dose administration of study agent for this study (Day 0) until Day 56 |
|
|
|
| 0 |
| 20 |
| 8 |
| 20 |
| Headache | Nervous system disorders | MeDRA | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MeDRA | Systematic Assessment |
|
| Pain | General disorders | MeDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MeDRA | Systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MeDRA | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MeDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Measurements |
|---|---|
|
| Leukocytosis, Grade 4 |
|
| Leukopenia, Grade 1 |
|
| Leukopenia, Grade 2 |
|
| Leukopenia, Grade 3 |
|
| Leukopenia, Grade 4 |
|
| Lymphopenia, Grade 1 |
|
| Lymphopenia, Grade 2 |
|
| Lymphopenia, Grade 3 |
|
| Lymphopenia, Grade 4 |
|
| Neutropenia, Grade 1 |
|
| Neutropenia, Grade 2 |
|
| Neutropenia, Grade 3 |
|
| Neutropenia, Grade 4 |
|
| Hemoglobin, Grade 1 |
|
| Hemoglobin, Grade 2 |
|
| Hemoglobin, Grade 3 |
|
| Hemoglobin, Grade 4 |
|
| Platelet, Grade 1 |
|
| Platelet, Grade 2 |
|
| Platelet, Grade 3 |
|
| Platelet, Grade 4 |
|
| Prothrombin Time, Grade 1 |
|
| Prothrombin Time, Grade 2 |
|
| Prothrombin Time, Grade 3 |
|
| Prothrombin Time, Grade 4 |
|
| Partial Thromboplastin Time, Grade 1 |
|
| Partial Thromboplastin Time, Grade 2 |
|
| Partial Thromboplastin Time, Grade 3 |
|
| Partial Thromboplastin Time, Grade 4 |
|
| Title | Measurements |
|---|---|
|
| Neutropenia, any >=2-grade worsening |
|
| Hemoglobin, any>=2-grade worsening |
|
| Platelet, any>=2-grade worsening |
|
| Prothrombin Time, any >=2-grade worsening |
|
| Partial Thromboplastin Time, any>=2grade worsening |
|
| Title | Measurements |
|---|---|
|
| AST, Grade 4 |
|
| Alanine amino transferase(ALT), Grade 1 |
|
| ALT, Grade 2 |
|
| ALT, Grade 3 |
|
| ALT, Grade 4 |
|
| Gamma-glutayl-transferase (GGT), Grade 1 |
|
| GGT, Grade 2 |
|
| GGT, Grade 3 |
|
| GGT, Grade 4 |
|
| Alkaline Phosphatase, Grade 1 |
|
| Alkaline Phosphatase, Grade 2 |
|
| Alkaline Phosphatase, Grade 3 |
|
| Alkaline Phosphatase, Grade 4 |
|
| Hyperbilirubinemia, Grade 1 |
|
| Hyperbilirubinemia, Grade 2 |
|
| Hyperbilirubinemia, Grade 3 |
|
| Hyperbilirubinemia, Grade 4 |
|
| Title | Measurements |
|---|---|
|
| Alkaline phosphatase, any>=2-grade worsening |
|
| Hyperbilirubinemia, any>=2-grade worsening |
|
| Title | Measurements |
|---|---|
|
| Hypernatremia, Grade 4 |
|
| Hyponatremia, Grade 1 |
|
| Hyponatremia, Grade 2 |
|
| Hyponatremia, Grade 3 |
|
| Hyponatremia, Grade 4 |
|
| Hyperkalemia, Grade 1 |
|
| Hyperkalemia, Grade 2 |
|
| Hyperkalemia, Grade 3 |
|
| Hyperkalemia, Grade 4 |
|
| Hypokalemia, Grade 1 |
|
| Hypokalemia, Grade 2 |
|
| Hypokalemia, Grade 3 |
|
| Hypokalemia, Grade 4 |
|
| Hypomagnesemia, Grade 1 |
|
| Hypomagnesemia, Grade 2 |
|
| Hypomagnesemia, Grade 3 |
|
| Hypomagnesemia, Grade 4 |
|
| Hypercalcemia, Grade 1 |
|
| Hypercalcemia, Grade 2 |
|
| Hypercalcemia, Grade 3 |
|
| Hypercalcemia, Grade 4 |
|
| Hypocalcemia, Grade 1 |
|
| Hypocalcemia, Grade 2 |
|
| Hypocalcemia, Grade 3 |
|
| Hypocalcemia, Grade 4 |
|
| Hypophosphatemia, Grade 1 |
|
| Hypophosphatemia, Grade 2 |
|
| Hypophosphatemia, Grade 3 |
|
| Hypophosphatemia, Grade 4 |
|
| Title | Measurements |
|---|---|
|
| Hypokalemia, any>=2-grade worsening |
|
| Hypomagnesemia, any>=2-grade worsening |
|
| Hypercalcemia, any>=2-grade worsening |
|
| Hypocalcemia, any>=2-grade worsening |
|
| Hypophosphatemia, any>=2-grade worsening |
|
| Title | Measurements |
|---|---|
|
| Creatinine, Grade 4 |
|
| Hypoalbuminemia, Grade 1 |
|
| Hypoalbuminemia, Grade 2 |
|
| Hypoalbuminemia, Grade 3 |
|
| Hypoalbuminemia, Grade 4 |
|
| Hyperuricemia, Grade 1 |
|
| Hyperuricemia, Grade 2 |
|
| Hyperuricemia, Grade 3 |
|
| Hyperuricemia, Grade 4 |
|
| Hyperglycemia, Grade 1 |
|
| Hyperglycemia, Grade 2 |
|
| Hyperglycemia, Grade 3 |
|
| Hyperglycemia, Grade 4 |
|
| Hypoglycemia, Grade 1 |
|
| Hypoglycemia, Grade 2 |
|
| Hypoglycemia, Grade 3 |
|
| Hypoglycemia, Grade 4 |
|
| Amylase, Grade 1 |
|
| Amylase, Grade 2 |
|
| Amylase, Grade 3 |
|
| Amylase, Grade 4 |
|
| Title | Measurements |
|---|---|
|
| Hyperglycemia, any>=2-grade worsening |
|
| Hypoglycemia, any>=2-grade worsening |
|
| Amylase, any>=2-grade worsening |
|
| Title | Measurements |
|---|---|
|
| Day 1 |
|
| Day 3 |
|
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 28 |
|
| Day 42 |
|
| Day 56 |
|