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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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This study, as a post-marketing commitment to the Food and Drug Administration, is designed to detect the effect of raxibacumab on anthrax vaccine adsorbed (AVA) immunogenicity in a healthy volunteer population. This is a randomized, open-label, parallel group, two arm study to compare the immunogenicity of AVA at 4 weeks after the first AVA dose, when AVA is administered alone or concomitantly with raxibacumab. The study is planned to enroll approximately 30 to 534 subjects in up to 3 cohorts. The total duration of the study will be approximately 26 weeks. The dates reflect cohort 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anthrax Vaccine Adsorbed | Experimental | Subjects will be administered subcutaneous (SC) 0.5 mL AVA doses on Days 1, 15, and 29 (0, 2, and 4 weeks). |
|
| AVA + Raxibacumab | Experimental | Subjects will be administered SC 0.5 mL AVA doses on Days 1, 15, and 29 (0, 2, and 4 weeks), with the first AVA dose administered immediately after completion of a single intravenous (IV) infusion 40 milligram (mg)/kilogram (kg) raxibacumab dose. Subjects will be premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVA | Biological | Sterile, milky-white suspension with dosage level of 0.5 mL for SC administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of Geometric Mean Concentrations (GMC) of Anti-protective Antigen (PA) Antibody (Ab) at 4 Weeks (Day 29) After the First AVA Dose (Prior to the Third AVA Dose), Between the AVA Alone and the AVA With Raxibacumab Treatment Groups | Ratio of the GMC of anti-PA Ab between AVA alone and the AVA with raxibacumab treatment group was assessed to compare the immunogenicity of AVA at 4 weeks after the first AVA dose (prior to the third AVA dose). Serum AVA derived anti-PA Ab concentrations were determined using an approved immunoassay. Per Protocol (PP) population was used in analysis which comprised of all analyzable participants (those who received at least the Week 0 [Day 1] and Week 2 [Day 15] AVA doses within the protocol specified visit window; receive the raxibacumab dose, if randomized to Treatment Group 2 and; completed the primary study endpoint assessment [anti-PA Ab concentration at Week 4]). | Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of GMC of Anti-PA Ab at Weeks 8 and 26 (Days 57 and 183) After the First AVA Dose, Between the AVA Alone and AVA With Raxibacumab Treatment Groups | Anti-PA antibody concentrations were collected at Weeks 8 and 26 after the first AVA dose. Serum AVA derived anti-PA Ab concentrations were determined using an approved immunoassay. The GMCs with corresponding 95% CI were calculated for each treatment group at each timepoint. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
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Inclusion Criteria:
Non-reproductive potential defined as:
Pre-menopausal females with one of the following: Documented tubal ligation, Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, Hysterectomy, Documented Bilateral Oophorectomy Postmenopausal defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment.
Reproductive potential and agrees to follow one of the options listed in the GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP), from 30 days prior to the first dose of study medication and until after the last dose of study medication and completion of the follow-up visit at Day 183 (at least five terminal half-lives for raxibacumab).
Exclusion Criteria:
An average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 g of alcohol: 12 ounces (360 milliliter [mL]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
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| Name | Affiliation | Role |
|---|---|---|
| Paul-Andre deLame, MD | Emergent BioSolutions Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Edgewater | Florida | 32132 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32333847 | Derived | Skoura N, Wang-Jairaj J, Della Pasqua O, Chandrasekaran V, Billiard J, Yeakey A, Smith W, Steel H, Tan LK. Effect of raxibacumab on immunogenicity of Anthrax Vaccine Adsorbed: a phase 4, open-label, parallel-group, randomised non-inferiority study. Lancet Infect Dis. 2020 Aug;20(8):983-991. doi: 10.1016/S1473-3099(20)30069-4. Epub 2020 Apr 22. |
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A total of 573 participants were randomized with 566 receiving study treatment and 537 completed the study.
This study included healthy volunteers who were not previously immunized against protective antigen. 573 participants were randomized with 566 receiving study treatment and 537 completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | AVA Alone | Participants administered Anthrax vaccine adsorbed (AVA) subcutaneous (SC) 0.5 milliliter (mL) on Days 1, 15 and 29 |
| FG001 | AVA+Raxibacumab | Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29. with the first AVA dose administered immediately after completion of a single 40 milligram/kilogram (mg/kg) intravenous (IV) infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Intent to Treat (ITT) Population comprised of all randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | AVA Alone | Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29 |
| BG001 | AVA+Raxibacumab | Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The ITT Population comprised of all randomized participants |
| 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 | Ratio of Geometric Mean Concentrations (GMC) of Anti-protective Antigen (PA) Antibody (Ab) at 4 Weeks (Day 29) After the First AVA Dose (Prior to the Third AVA Dose), Between the AVA Alone and the AVA With Raxibacumab Treatment Groups | Ratio of the GMC of anti-PA Ab between AVA alone and the AVA with raxibacumab treatment group was assessed to compare the immunogenicity of AVA at 4 weeks after the first AVA dose (prior to the third AVA dose). Serum AVA derived anti-PA Ab concentrations were determined using an approved immunoassay. Per Protocol (PP) population was used in analysis which comprised of all analyzable participants (those who received at least the Week 0 [Day 1] and Week 2 [Day 15] AVA doses within the protocol specified visit window; receive the raxibacumab dose, if randomized to Treatment Group 2 and; completed the primary study endpoint assessment [anti-PA Ab concentration at Week 4]). | PP Population. | Posted | Geometric Mean | 95% Confidence Interval | Microgram/milliliter (µg/mL) | Day 29 |
|
On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183.
Safety Population
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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 | AVA Alone | Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bile Duct Stone | Hepatobiliary disorders | 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 25, 2016 | Nov 14, 2017 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 24, 2015 | Nov 14, 2017 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C542124 | raxibacumab |
| D004155 | Diphenhydramine |
| ID | Term |
|---|---|
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D001559 | Benzhydryl Compounds |
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| Raxibacumab | Biological | Sterile, liquid formulation with unit dose strength of 40 mg/ kg for IV administration |
|
| Diphenhydramine | Drug | Depending upon the labelling of the specific product chosen, 25 - 50 mg will be administered orally or IV |
|
| Days 57 and 183 |
| Percentage of Participants Who Seroconvert, at Weeks 4, 8, and 26 (Days 29, 57 and 183) After the First AVA Dose, Between the AVA Alone and the AVA With Raxibacumab Treatment Groups | The percentage of participants, with corresponding 95% CI based on Wilson's method, who seroconvert (seroconversion is defined as a >4-fold increase in toxin neutralizing activity [TNA] titer) was summarized, at Weeks 4, 8 and 26 after the first AVA dose for both arms separately. Serum TNA titer was determined using a cell-based assay. | Days 29, 57 and 183 |
| Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (AE) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE resulting in death, is life threatening (ie, an immediate threat to life), inpatient hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or any other situation which is medically important and may jeopardize the participant or may require medical or surgical intervention or events associated with liver injury and impaired liver function is categorized as SAE. The Safety population was comprised of all randomized participants who received at least one dose of AVA. | Up to Day 183 |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP and DBP were measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | Baseline and up to Day 183 |
| Change From Baseline in Heart Rate at Indicated Time Points | Heart rate was measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | Baseline and up to Day 183 |
| Change From Baseline in Respiratory Rate at Indicated Time Points | Respiratory rate was measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | Baseline and up to Day 183 |
| Change From Baseline in Temperature at Indicated Time Points | Temperature was measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | Baseline and up to Day 183 |
| Number of Participants With Hematology Parameters Outside Normal Range | Hematology parameters included assessment of platelet count, erythrocytes, leukocytes , reticulocyte count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils, basophils, hemoglobin and hematocrit. Here high is equal to above the upper limit of the normal range, low is equal to below the lower limit of the normal range. Participants are counted in the category that their value changes to (low, normal or high), unless there is no change in their category. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | Up to Day 57 |
| Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Blood samples were collected to evaluate clinical chemistry parameters, which included assessment of urea nitrogen (UN), creatinine, chloride, glucose, magnesium, total protein, potassium, chloride, total Carbon dioxide (CO2), sodium, calcium (cal), alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltransferase (GGT), total and direct bilirubin ( D.bili), albumin and calculated creatinine clearance. Here high is equal to above the upper limit of the normal range, low is equal to below the lower limit of the normal range. Participants are counted in the category that their value changes to (low, normal or high), unless there is no change in their category. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | Up to Day 57 |
| Number of Participants With Urinalysis Parameters | Urinalysis parameters included amorphous crystals, bacteria, bilirubin, calcium oxalate (Ca Ox) crystals, choriogonadotropin beta, clarity, color, crystals of Ca Ox, erythrocytes, glucose, hemoglobin, ketone bodies, ketones, leukocyte cell clumps, leukocyte esterase, leukocytes, mucous threads, nitrite, occult blood, protein, specific gravity, squamous epithelial cells, turbidity, urobilinogen, and transitional epithelial cells. In urinalysis test plus sign (+) indicates increase in the level of the parameters. | Day 57 |
| Overland Park |
| Kansas |
| 66211 |
| United States |
| GSK Investigational Site | Knoxville | Tennessee | 37920 | United States |
| Lost to Follow-up |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | ITT | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | ITT | Count of Participants | Participants |
|
| AVA Alone |
Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29 |
| OG001 | AVA+Raxibacumab | Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions. |
|
|
|
| Secondary | Ratio of GMC of Anti-PA Ab at Weeks 8 and 26 (Days 57 and 183) After the First AVA Dose, Between the AVA Alone and AVA With Raxibacumab Treatment Groups | Anti-PA antibody concentrations were collected at Weeks 8 and 26 after the first AVA dose. Serum AVA derived anti-PA Ab concentrations were determined using an approved immunoassay. The GMCs with corresponding 95% CI were calculated for each treatment group at each timepoint. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | PP Population. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Days 57 and 183 |
|
|
|
|
| Secondary | Percentage of Participants Who Seroconvert, at Weeks 4, 8, and 26 (Days 29, 57 and 183) After the First AVA Dose, Between the AVA Alone and the AVA With Raxibacumab Treatment Groups | The percentage of participants, with corresponding 95% CI based on Wilson's method, who seroconvert (seroconversion is defined as a >4-fold increase in toxin neutralizing activity [TNA] titer) was summarized, at Weeks 4, 8 and 26 after the first AVA dose for both arms separately. Serum TNA titer was determined using a cell-based assay. | PP Population. | Posted | Number | 95% Confidence Interval | Percent of Participants | Days 29, 57 and 183 |
|
|
|
| Secondary | Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (AE) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE resulting in death, is life threatening (ie, an immediate threat to life), inpatient hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or any other situation which is medically important and may jeopardize the participant or may require medical or surgical intervention or events associated with liver injury and impaired liver function is categorized as SAE. The Safety population was comprised of all randomized participants who received at least one dose of AVA. | Safety Population | Posted | Number | Participants | Up to Day 183 |
|
|
|
| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP and DBP were measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | Safety Population | Posted | Mean | Standard Deviation | Millimeter of mercury (mmHg) | Baseline and up to Day 183 |
|
|
|
| Secondary | Change From Baseline in Heart Rate at Indicated Time Points | Heart rate was measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | Safety Population | Posted | Mean | Standard Deviation | Beats per minute (bpm) | Baseline and up to Day 183 |
|
|
|
| Secondary | Change From Baseline in Respiratory Rate at Indicated Time Points | Respiratory rate was measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | Safety Population | Posted | Mean | Standard Deviation | Breaths per minute | Baseline and up to Day 183 |
|
|
|
| Secondary | Change From Baseline in Temperature at Indicated Time Points | Temperature was measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | Safety Population | Posted | Mean | Standard Deviation | Degree celsius | Baseline and up to Day 183 |
|
|
|
| Secondary | Number of Participants With Hematology Parameters Outside Normal Range | Hematology parameters included assessment of platelet count, erythrocytes, leukocytes , reticulocyte count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils, basophils, hemoglobin and hematocrit. Here high is equal to above the upper limit of the normal range, low is equal to below the lower limit of the normal range. Participants are counted in the category that their value changes to (low, normal or high), unless there is no change in their category. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | Safety Population | Posted | Number | Participants | Up to Day 57 |
|
|
|
| Secondary | Number of Participants With Clinical Chemistry Parameters Outside Normal Range | Blood samples were collected to evaluate clinical chemistry parameters, which included assessment of urea nitrogen (UN), creatinine, chloride, glucose, magnesium, total protein, potassium, chloride, total Carbon dioxide (CO2), sodium, calcium (cal), alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltransferase (GGT), total and direct bilirubin ( D.bili), albumin and calculated creatinine clearance. Here high is equal to above the upper limit of the normal range, low is equal to below the lower limit of the normal range. Participants are counted in the category that their value changes to (low, normal or high), unless there is no change in their category. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. | Safety Population. | Posted | Number | Participants | Up to Day 57 |
|
|
|
| Secondary | Number of Participants With Urinalysis Parameters | Urinalysis parameters included amorphous crystals, bacteria, bilirubin, calcium oxalate (Ca Ox) crystals, choriogonadotropin beta, clarity, color, crystals of Ca Ox, erythrocytes, glucose, hemoglobin, ketone bodies, ketones, leukocyte cell clumps, leukocyte esterase, leukocytes, mucous threads, nitrite, occult blood, protein, specific gravity, squamous epithelial cells, turbidity, urobilinogen, and transitional epithelial cells. In urinalysis test plus sign (+) indicates increase in the level of the parameters. | Safety Population | Posted | Number | Participants | Day 57 |
|
|
|
| 286 |
| 5 |
| 286 |
| 85 |
| 286 |
| EG001 | Raxibacumab Only and Discontinued Due to AE During Raxibacumab Infusion | During the study, six of 286 raxibacumab-treated subjects (2.1%) had adverse events (AEs) to raxibacumab that required drug discontinuation, administration of additional medications for mitigation of signs and symptoms, and discontinuation from the study. This new arm is included to capture safety data for these 6 subjects. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG002 | AVA + Raxibacumab With no AE During Raxibacumab Infusion That Led to Discontinuation | Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions. | 1 | 280 | 3 | 280 | 80 | 280 |
| Cholecystitis | Hepatobiliary disorders | 20.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | 20.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | 20.0 | Systematic Assessment |
|
| Toxicity To Various Agents | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
|
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | 20.0 | Systematic Assessment |
|
| Completed Suicide | Psychiatric disorders | 20.0 | Systematic Assessment |
|
| Suicidal Ideation | Psychiatric disorders | 20.0 | Systematic Assessment |
|
| Asphyxia | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
|
| Ear Discomfort | Ear and labyrinth disorders | 20.0 | Systematic Assessment |
|
| Visual Impairment | Eye disorders | 20.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 20.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 20.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | 20.0 | Systematic Assessment |
|
| Abdominal Discomfort | Gastrointestinal disorders | 20.0 | Systematic Assessment |
|
| Abdominal Pain Lower | Gastrointestinal disorders | 20.0 | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | 20.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | 20.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | 20.0 | Systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | 20.0 | Systematic Assessment |
|
| Rectal Haemorrhage | Gastrointestinal disorders | 20.0 | Systematic Assessment |
|
| Injection Site Reaction | General disorders | 20.0 | Systematic Assessment |
|
| Injection Site Erythema | General disorders | 20.0 | Systematic Assessment |
|
| Injection Site Pain | General disorders | 20.0 | Systematic Assessment |
|
| Injection Site Swelling | General disorders | 20.0 | Systematic Assessment |
|
| Injection Site Pruritus | General disorders | 20.0 | Systematic Assessment |
|
| Fatigue | General disorders | 20.0 | Systematic Assessment |
|
| Injection Site Nodule | General disorders | 20.0 | Systematic Assessment |
|
| Feeling hot | General disorders | 20.0 | Systematic Assessment |
|
| Pain | General disorders | 20.0 | Systematic Assessment |
|
| Pyrexia | General disorders | 20.0 | Systematic Assessment |
|
| Asthenia | General disorders | 20.0 | Systematic Assessment |
|
| Catheter Site Pain | General disorders | 20.0 | Systematic Assessment |
|
| Chest Discomfort | General disorders | 20.0 | Systematic Assessment |
|
| Induration | General disorders | 20.0 | Systematic Assessment |
|
| Infusion Site Bruising | General disorders | 20.0 | Systematic Assessment |
|
| Infusion Site Extravasation | General disorders | 20.0 | Systematic Assessment |
|
| Injection Site Mass | General disorders | 20.0 | Systematic Assessment |
|
| Injection Site Rash | General disorders | 20.0 | Systematic Assessment |
|
| Local Swelling | General disorders | 20.0 | Systematic Assessment |
|
| Peripheral Swelling | General disorders | 20.0 | Systematic Assessment |
|
| Vaccination Site Reaction | General disorders | 20.0 | Systematic Assessment |
|
| Seasonal Allergy | Immune system disorders | 20.0 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | 20.0 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | 20.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | 20.0 | Systematic Assessment |
|
| Viral Upper Respiratory Tract Infection | Infections and infestations | 20.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | 20.0 | Systematic Assessment |
|
| Pharyngitis Streptococcal | Infections and infestations | 20.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | 20.0 | Systematic Assessment |
|
| Tooth Infection | Infections and infestations | 20.0 | Systematic Assessment |
|
| Acute Sinusitis | Infections and infestations | 20.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | 20.0 | Systematic Assessment |
|
| Furuncle | Infections and infestations | 20.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | 20.0 | Systematic Assessment |
|
| Tooth Abscess | Infections and infestations | 20.0 | Systematic Assessment |
|
| Ligament Sprain | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
|
| Muscle Strain | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
|
| Animal Bite | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
|
| Arthropod Bite | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
|
| Foot Fracture | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
|
| Infusion Related Reaction | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
|
| Limb Injury | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
|
| Road Traffic Accident | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
|
| Skin Injury | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
|
| Upper Limb Fracture | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | 20.0 | Systematic Assessment |
|
| Blood Creatine Phosphokinase Increased | Investigations | 20.0 | Systematic Assessment |
|
| Hepatic Enzyme Increased | Investigations | 20.0 | Systematic Assessment |
|
| Lymphocyte Count Decreased | Investigations | 20.0 | Systematic Assessment |
|
| Neutrophil Count Decreased | Investigations | 20.0 | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
|
| Muscle Tightnes | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
|
| Flank Pain | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
|
| Muscle Fatigue | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | 20.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | 20.0 | Systematic Assessment |
|
| Nerve Compression | Nervous system disorders | 20.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | 20.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | 20.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | 20.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | 20.0 | Systematic Assessment |
|
| Loss Of Libido | Psychiatric disorders | 20.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | 20.0 | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
|
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
|
| Dry Throat | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
|
| Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
|
| Throat Tightness | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
|
| Dermatitis Contact | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
|
| Miliaria | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
|
| Pruritus Generalised | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
|
| Rash Erythematous | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
|
| Rash Generalised | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | 20.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | 20.0 | Systematic Assessment |
|
| Hot Flush | Vascular disorders | 20.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | 20.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | 20.0 | 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.
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Week 26, n=267, 258 |
|
|
| Ratio |
| 0.98 |
| 2-Sided |
| 90 |
| 0.89 |
| 1.07 |
Week 26 |
| Other |
| Week 26 |
|
| SBP, Day 29, n=283, 279 |
|
|
| SBP, Day 57, n=282, 275 |
|
|
| SBP, Day 183, n=273, 266 |
|
|
| DBP, Day 1, n=286, 280 |
|
|
| DBP, Day 29, n=283, 279 |
|
|
| DBP, Day 57, n=282, 275 |
|
|
| DBP, Day 183, n=273, 266 |
|
|
| Day 29, n=283, 279 |
|
|
| Day 57, n=282, 275 |
|
|
| Day 183, n=273, 266 |
|
|
| Day 29, n=283, 279 |
|
|
| Day 57, n=282, 276 |
|
|
| Day 183, n=273, 266 |
|
|
| Day 29, n=283, 279 |
|
|
| Day 57, n=282, 276 |
|
|
| Day 183, n=272, 266 |
|
|
| Eosinophils 10^9/L High, Week 4, n=282, 278 |
|
|
| Eosinophils 10^9/L, Low, Week 8, n=281, 276 |
|
|
| Eosinophils 10^9/L, High, Week 8, n=281, 276 |
|
|
| Basophils 10^9/L, Low, Week 4, n=282, 278 |
|
|
| Basophils 10^9/L, High, Week 4, n=282, 278 |
|
|
| Basophils 10^9/L, Low, Week 8, n=281, 276 |
|
|
| Basophils 10^9/L, High, Week 8, n=281, 276 |
|
|
| Hematocrit percent (%) Low, Week 4, n=283, 279 |
|
|
| Hematocrit %, High, Week 4, n=283, 279 |
|
|
| Hematocrit %, Low, Week 8, n=281, 276 |
|
|
| Hematocrit %, High, Week 8, n=281, 276 |
|
|
| Hemoglobin gram/Liter (g/L) Low,Week 4,n=283, 279 |
|
|
| Hemoglobin g/L, High, Week 4, n=283, 279 |
|
|
| Hemoglobin g/L, Low, Week 8, n=281, 276 |
|
|
| Hemoglobin g/L, High, Week 8, n=281, 276 |
|
|
| Lymphocytes 10^9/L , Low, Week 4, n=282, 278 |
|
|
| Lymphocytes 10^9/L , High, Week 4, n=282, 278 |
|
|
| Lymphocytes 10^9/L, Low, Week 8, n=281, 276 |
|
|
| Lymphocytes 10^9/L, High, Week 8, n=281, 276 |
|
|
| MCH picogram (pg), Low, Week 4, n=283, 279 |
|
|
| MCH pg, High, Week 4, n=283, 279 |
|
|
| MCH pg, Low, Week 8, n=281, 276 |
|
|
| MCH pg, High, Week 8, n=281, 276 |
|
|
| MCHC g/L, Low, Week 4, n=283, 279 |
|
|
| MCHC g/L, High, Week 4, n=283, 279 |
|
|
| MCHC g/L, Low, Week 8, n=281, 276 |
|
|
| MCHC g/L, High, Week 8, n=281, 276 |
|
|
| MCV femtoliters (fL), Low, Week 4, n=283, 279 |
|
|
| MCV fL, High, Week 4, n=283, 279 |
|
|
| MCV fL, Low, Week 8, n=281, 276 |
|
|
| MCV fL, High, Week 8, n=281, 276 |
|
|
| Monocytes 10^9/L , Low, Week 4, n=282, 278 |
|
|
| Monocytes 10^9/L, High, Week 4, n=282, 278 |
|
|
| Monocytes 10^9/L, Low, Week 8, n=281, 276 |
|
|
| Monocytes 10^9/L, High, Week 8, n=281, 276 |
|
|
| Neutrophils 10^9/L, Low, Week 4, n=283, 279 |
|
|
| Neutrophils 10^9/L, High, Week 4, n=283, 279 |
|
|
| Neutrophils 10^9/L, Low, Week 8, n=281, 276 |
|
|
| Neutrophils 10^9/L, High, Week 8, n=281, 276 |
|
|
| Erythrocytes 10^12/L, Low, Week 4, n=283, 279 |
|
|
| Erythrocytes 10^12/L, High, Week 4, n=283, 279 |
|
|
| Erythrocytes 10^12/L, Low, Week 8, n=281, 276 |
|
|
| Erythrocytes 10^12/L, High, Week 8, n=281, 276 |
|
|
| Leukocytes 10^9/L, Low, Week 4, n=283, 279 |
|
|
| Leukocytes 10^9/L, High, Week 4, n=283, 279 |
|
|
| Leukocytes 10^9/L, Low, Week 8, n=281, 276 |
|
|
| Leukocytes 10^9/L, High, Week 8, n=281, 276 |
|
|
| Reticulocytes 10^12/L, Low, Week 4, n=283, 279 |
|
|
| Reticulocytes 10^12/L, High, Week 4, n=283, 279 |
|
|
| Reticulocytes 10^12/L, Low, Week 8, n=281, 276 |
|
|
| Reticulocytes 10^12/L, High, Week 8, n=281, 276 |
|
|
| Platelet 10^9/L, Low, Week 4, n=282, 279 |
|
|
| Platelet 10^9/L, High, Week 4, n=282, 279 |
|
|
| Platelet 10^9/L, Low, Week 8, n=280, 276 |
|
|
| Platelet 10^9/L, High, Week 8, n=280, 276 |
|
|
| Albumin g/L, High, Week 4, n=283, 279 |
|
|
| Albumin g/L, Low, Week 8, n=282, 275 |
|
|
| Albumin g/L, High, Week 8, n=282, 275 |
|
|
| ALP units/liter (U/L), Low, Week 4, n=283, 279 |
|
|
| ALP U/L, High, Week 4, n=283, 279 |
|
|
| ALP U/L, Low, Week 8, n=282, 275 |
|
|
| ALP U/L, High, Week 8, n=282, 275 |
|
|
| ALT U/L, Low, Week 4, n=283, 279 |
|
|
| ALT U/L, High, Week 4, n=283, 279 |
|
|
| ALT U/L, Low, Week 8, n=282, 275 |
|
|
| ALT U/L, High, Week 8, n=282, 275 |
|
|
| AST U/L, Low, Week 4, n=283, 279 |
|
|
| AST U/L, High, Week 4, n=283, 279 |
|
|
| AST U/L, Low, Week 8, n=282, 275 |
|
|
| AST U/L, High, Week 8, n=282, 275 |
|
|
| D.bili micromole/Liter (µmol/L) LowWeek4,n=274,263 |
|
|
| D.bili µmol/L, High, Week 4, n=274, 263 |
|
|
| D.bili µmol/L, Low, Week 8, n=274, 261 |
|
|
| D.bili µmol/L, High, Week 8, n=274, 261 |
|
|
| Bili µmol/L, Low, Week 4, n=280, 279 |
|
|
| Bili µmol/L, High, Week 4, n=280, 279 |
|
|
| Bili µmol/L, Low, Week 8, n=280, 273 |
|
|
| Bili µmol/L, High, Week 8, n=280, 273 |
|
|
| Cal,millimole/Liter (mmol/L)Low,Week 4,n=283, 279 |
|
|
| Cal mmol/L, High, Week 4, n=283, 279 |
|
|
| Cal mmol/L, Low, Week 8, n=282, 275 |
|
|
| Cal mmol/L, High, Week 8, n=282, 275 |
|
|
| Chloride mmol/L, Low, Week 4, n=283, 279 |
|
|
| Chloride mmol/L, High, Week 4, n=283, 279 |
|
|
| Chloride mmol/L, Low, Week 8, n=282, 275 |
|
|
| Chloride mmol/L, High, Week 8, n=282, 275 |
|
|
| CO2 mmol/L, Low, Week 4, n=283, 279 |
|
|
| CO2 mmol/L, High, Week 4, n=283, 279 |
|
|
| CO2 mmol/L, Low, Week 8, n=282, 275 |
|
|
| CO2 mmol/L, High, Week 8, n=282, 275 |
|
|
| Creatinine µmol/L, Low, Week 4, n=283, 279 |
|
|
| Creatinine µmol/L, High, Week 4, n=283, 279 |
|
|
| Creatinine µmol/L, Low, Week 8, n=282, 275 |
|
|
| Creatinine µmol/L, High, Week 8, n=282, 275 |
|
|
| GGT U/L, Low, Week 4, n=283, 279 |
|
|
| GGT U/L, High, Week 4, n=283, 279 |
|
|
| GGT U/L, Low, Week 8, n=282, 275 |
|
|
| GGT U/L, High, Week 8, n=282, 275 |
|
|
| Glucose mmol/L, Low, Week 4, n=283, 279 |
|
|
| Glucose mmol/L, High, Week 4, n=283, 279 |
|
|
| Glucose mmol/L, Low, Week 8, n=282, 275 |
|
|
| Glucose mmol/L, High, Week 8, n=282, 275 |
|
|
| Potassium mmol/L, Low, Week 4, n=283, 279 |
|
|
| Potassium mmol/L, High, Week 4, n=283, 279 |
|
|
| Potassium mmol/L, Low, Week 8, n=282, 275 |
|
|
| Potassium mmol/L, High, Week 8, n=282, 275 |
|
|
| Magnesium mmol/L, Low, Week 4, n=283, 279 |
|
|
| Magnesium mmol/L, High, Week 4, n=283, 279 |
|
|
| Magnesium mmol/L, Low, Week 8, n=282, 275 |
|
|
| Magnesium mmol/L, High, Week 8, n=282, 275 |
|
|
| Protein g/L, Low, Week 4, n=283, 279 |
|
|
| Protein g/L, High, Week 4, n=283, 279 |
|
|
| Protein g/L, Low, Week 8, n=282, 275 |
|
|
| Protein g/L, High, Week 8, n=282, 275 |
|
|
| Sodium mmol/L, Low, Week 4, n=283, 279 |
|
|
| Sodium mmol/L, High, Week 4, n=283, 279 |
|
|
| Sodium mmol/L, Low, Week 8, n=282, 275 |
|
|
| Sodium mmol/L, High, Week 8, n=282, 275 |
|
|
| Urate µmol/L, Low, Week 4, n=283, 279 |
|
|
| Urate µmol/L, High, Week 4, n=283, 279 |
|
|
| Urate µmol/L, Low, Week 8, n=282, 275 |
|
|
| Urate µmol/L, High, Week 8, n=282, 275 |
|
|
| UN mmol/L, Low, Week 4, n=283, 279 |
|
|
| UN mmol/L, High, Week 4, n=283, 279 |
|
|
| UN mmol/L, Low, Week 8, n=282, 275 |
|
|
| UN mmol/L, High, Week 8, n=282, 275 |
|
|
| Amorphous crystals 3+ |
|
| Amorphous crystals 4+ |
|
| Amorphous crystals trace |
|
| Bacteria 1+ |
|
| Bacteria 2+ |
|
| Bacteria 3+ |
|
| Bacteria 4+ |
|
| Bacteria few |
|
| Bacteria many |
|
| Bacteria mod |
|
| Bacteria Occ |
|
| Bacteria rare |
|
| Bacteria trace |
|
| Bilirubin 1+ |
|
| Bilirubin negative |
|
| Bilirubin small |
|
| Ca Ox Crystals few |
|
| Ca Ox Crystals rare |
|
| Choriogonadotropin Beta negative |
|
| Choriogonadotropin Beta positive |
|
| Clarity, clear |
|
| Clarity, cloudy |
|
| Clarity turbid |
|
| Color amber |
|
| Color colorless |
|
| Color light-red |
|
| Color light-yellow |
|
| Color yellow |
|
| Crystals Ca-Ox |
|
| Erythrocytes 0-2 |
|
| Erythrocytes 10-25 |
|
| Erythrocytes 2-5 |
|
| Erythrocytes 25-50 |
|
| Erythrocytes 5-10 |
|
| Erythrocytes 50-99 |
|
| Erythrocytes innumerable |
|
| Erythrocytes less than 1 |
|
| Erythrocytes Tntc |
|
| Glucose positive |
|
| Glucose negative |
|
| Hemoglobin + |
|
| Hemoglobin ++ |
|
| Hemoglobin +++ |
|
| Hemoglobin large |
|
| Hemoglobin mod |
|
| Hemoglobin negative |
|
| Hemoglobin small |
|
| Hemoglobin trace |
|
| Ketone bodies negative |
|
| Ketone bodies trace |
|
| Ketones + |
|
| Ketones ++ |
|
| Ketones ++++ |
|
| Ketones mod |
|
| Ketones negative |
|
| Ketones trace |
|
| Leukocyte Cell Clumps Occ |
|
| Leukocyte Cell Clumps rare |
|
| Leukocyte Esterase 1+ |
|
| Leukocyte Esterase 2+ |
|
| Leukocyte Esterase 3+ |
|
| Leukocyte Esterase large |
|
| Leukocyte Esterase Mod |
|
| Leukocyte Esterase Moderate |
|
| Leukocyte Esterase negative |
|
| Leukocyte Esterase small |
|
| Leukocyte Esterase trace |
|
| Leukocyte + |
|
| Leukocyte ++ |
|
| Leukocyte +++ |
|
| Leukocyte 0-2 |
|
| Leukocyte 10-25 |
|
| Leukocyte 2-5 |
|
| Leukocyte 25-50 |
|
| Leukocyte 5-10 |
|
| Leukocyte less than 1 |
|
| Leukocyte large |
|
| Leukocyte mod |
|
| Leukocyte negative |
|
| Leukocyte small |
|
| Leukocyte trace |
|
| Mucous threads 2+ |
|
| Mucous Threads few |
|
| Mucous Threads many |
|
| Mucous Threads Mod |
|
| Mucous Threads trace |
|
| Nitrite negative |
|
| Nitrite positive |
|
| Occult Blood 1+ |
|
| Occult Blood 2+ |
|
| Occult Blood 3+ |
|
| Occult Blood large |
|
| Occult Blood mod |
|
| Occult Blood moderate |
|
| Occult Blood negative |
|
| Occult Blood small |
|
| Occult Blood trace |
|
| Protein + |
|
| Protein ++ |
|
| Protein ++++ |
|
| Protein 1+ |
|
| Protein large |
|
| Protein negative |
|
| Protein non-heam |
|
| Protein trace |
|
| Specific Gravity <=1.005 |
|
| Specific Gravity >=1.030 |
|
| Squamous Epithelial Cells 0-2 |
|
| Squamous Epithelial Cells 2-5 |
|
| Squamous Epithelial Cells 5-10 |
|
| Squamous Epithelial Cells <1 |
|
| Turbidity clear |
|
| Turbidity cloudy |
|
| Turbidity hazy |
|
| Urobilinogen <2.0 |
|
| Urobilinogen less than 2.0 |
|
| Urobilinogen normal |
|
| Transitional Epithelial Cells <1 |
|