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| ID | Type | Description | Link |
|---|---|---|---|
| IND 17154 | Other Identifier | FDA |
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Assess the safety of single infusions with RePlas FDP product at increasing fixed doses
This is a single-site, partial double-blind study in healthy volunteers designed to assess the safety of infusing ascending doses of reconstituted autologous freeze dried plasma (FDP) in 3 fixed-dose cohorts. Beginning with Cohort 1, subjects will receive a single infusion of 1 unit (approximately 270 mL) of either FDP manufactured from fresh frozen plasma (FFP) derived from autologous whole blood (WB) collection(s) that use citrate phosphate dextrose (CPD) as the anticoagulant (FDP-CPD) or FDP manufactured from FFP units from autologous plasmapheresis where acid citrate dextrose (ACD) is used as the anticoagulant (FDP-ACD). Recruitment of subjects for Cohort 2 follows the completion of infusions in Cohort 1. Subjects in Cohort 2 will receive a single infusion of 2 units (approximately 540 mL) of either FDP-CPD or FDP-ACD before recruitment for Cohort 3 is initiated. Subjects enrolled in Cohort 3 will receive the highest study dose, a plasma infusion dose of 3 units (approximately 810 mL) of FDP-ACD at one infusion visit and the same dose of autologous FFP at another infusion visit. Cohort 3 subjects will only be infused with FDP and FFP products sourced from autologous plasmapheresis. Randomization of Cohort 3 subjects to a treatment sequence determines whether they will be infused with 3 units of FDP or 3 units of FFP at their first infusion visit followed by infusion with the alternate product at the second infusion visit. A 2-week interval will be maintained between infusion visits in Cohort 3. Crossover of FDP and FFP enables comparison of infusion safety and select coagulation factor recoveries within the same subjects between FDP and FFP at this higher dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 unit FDP-CPD | Experimental | Subjects are to have sufficient plasma withdrawn during a single WB collection visit to allow re-infusion with 1 unit of autologous FDP-CPD |
|
| Reinfusion 1 unit FDP-ACD | Experimental | Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection visit to allow re-infusion with 1 unit of autologous FDP-ACD |
|
| Reinfusion 2 units FDP-CPD | Experimental | Subjects are to have sufficient plasma withdrawn during 2 separate WB collection visits to allow re-infusion with 2 units of autologous FDP-CPD |
|
| Reinfusion 2 units FDP-ACD | Experimental | Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection to allow re-infusion with 2 units of autologous FDP-ACD |
|
| Reinfusion 3 units FDP, 3 units FFP (1st) | Active Comparator | Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Freeze Dried Plasma (FDP) | Biological | Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Single Infusions of FDP at Increasing Fixed Doses in Normal Healthy Subjects by Evaluating Vital Signs and Laboratory Tests | Assess the safety of single infusions of FDP at increasing fixed doses of either 1 unit, 2 units, or 3 units in normal healthy subjects by evaluating vital signs during and after infusion | Follow-up assessments on days 2, 8, 29, and telephone assessments on days 3 and 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events | Assess the safety and tolerability of a fixed-dose infusion of 3 FDP units in comparison to infusion with the same dose of autologous Fresh Frozen Plasma (FFP) in normal healthy subjects by evaluating vital signs and laboratory tests | Follow-up assessments on days 2, 8, 16, 22, 43, and telephone assessments on days 3, 4, 17, and 18 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose A Cancelas, MD, PhD | Hoxworth Blood Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoxworth Blood Center | Cincinnati | Ohio | 45267 | United States |
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Of 40 screened participants, 30 met inclusion criteria and were enrolled. Six participants were withdrawn prior to receiving study treatment. Twenty four participants were infused with plasma.
Healthy volunteers were recruited at an academic medical center between February 2017 and March 2018. The first participant was enrolled on March 6, 2017 and the last participant was enrolled on April 5, 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Unit, Single Infusion FDP-CPD | Subjects are to have sufficient plasma withdrawn during a single WB collection visit to allow re-infusion with 1 unit of autologous FDP-CPD 270 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers |
| FG001 | 1 Unit, Single Infusion FDP-ACD | Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection visit to allow re-infusion with 1 unit of autologous FDP-ACD 270 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers |
| FG002 | 2 Units, Single Infusion FDP-CPD | Subjects are to have sufficient plasma withdrawn during 2 separate WB collection visits to allow re-infusion with 2 units of autologous FDP-CPD 540 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers |
| FG003 | 2 Units, Single Infusion FDP-ACD | Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection to allow re-infusion with 2 units of autologous FDP-ACD 540 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers |
| FG004 | 3 Units Per Crossover Infusion FDP-ACD x FFP | Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only |
| FG005 | 3 Units Per Crossover Infusion FFP x FDP-ACD | Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 Unit, Single Infusion FDP-CPD | Subjects are to have sufficient plasma withdrawn during a single WB collection visit to allow re-infusion with 1 unit of autologous FDP-CPD 270 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers |
| BG001 |
| 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 | Safety of Single Infusions of FDP at Increasing Fixed Doses in Normal Healthy Subjects by Evaluating Vital Signs and Laboratory Tests | Assess the safety of single infusions of FDP at increasing fixed doses of either 1 unit, 2 units, or 3 units in normal healthy subjects by evaluating vital signs during and after infusion | Posted | Count of Participants | Participants | Follow-up assessments on days 2, 8, 29, and telephone assessments on days 3 and 4 |
|
11.1 to 25.4 weeks
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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 | 1 Unit, Single Infusion FDP-CPD | Subjects are to have sufficient plasma withdrawn during a single WB collection visit to allow re-infusion with 1 unit of autologous FDP-CPD 270 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Cancelas, M.D., Ph.D. | University of Cincinnati | 513-558-1324 | Jose.Cancelas@cchmc.org |
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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 19, 2018 | Apr 3, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 11, 2018 | Apr 3, 2020 | SAP_001.pdf |
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|
| Reinfusion 3 units FDP, 3 units FFP (2nd) | Active Comparator | Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits |
|
| Fresh Frozen Plasma (FFP) | Biological | Controlled FFP in cohort 3 only |
|
| Number of Participants With Significant Changes in Specific Coagulation Values | Determine if the changes in specific coagulation values are similar with clinically meaningful levels pre and post infusion in the different arm groups by evaluating laboratory tests. Blood thrombin, Coombs direct test, Fibrin D dimer, and Thrombin-antithrombin III levels are determined through a blood test to check if your blood is clotting normally. Positive tests or any values below or above the normal reference range is considered abnormal. | For cohorts 1 and 2, follow-up assessments on days 2, 8 and 29. For cohort 3, follow-up assessments on days 2, 8, 16, 22, and 43. |
| Number of Participants With Significant Changes in Specific Hematology Values | Determine if the changes in specific hematology values are similar with clinically meaningful levels pre and post infusion in the different arm groups by evaluating laboratory tests. The specific hematology values are determined through a blood test. Any values below or above the normal reference range is considered abnormal. | For cohorts 1 and 2, follow-up assessments on days 2, 8 and 29. For cohort 3, follow-up assessments on days 2, 8, 16, 22, and 43. |
| Number of Participants With Significant Changes in Specific Chemistry Values | Determine if the changes in specific chemistry values are similar with clinically meaningful levels pre and post infusion in the different arm groups by evaluating laboratory tests. Glucose levels and liver function levels, ALT and AST, are determined through a blood test. Any values below or above the normal reference range is considered abnormal. | For cohorts 1 and 2, follow-up assessments on days 2, 8 and 29. For cohort 3, follow-up assessments on days 2, 8, 16, 22, and 43. |
| 1 Unit, Single Infusion FDP-ACD |
Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection visit to allow re-infusion with 1 unit of autologous FDP-ACD 270 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers |
| BG002 | 2 Units, Single Infusion FDP-CPD | Subjects are to have sufficient plasma withdrawn during 2 separate WB collection visits to allow re-infusion with 2 units of autologous FDP-CPD 540 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers |
| BG003 | 2 Units, Single Infusion FDP-ACD | Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection to allow re-infusion with 2 units of autologous FDP-ACD 540 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers |
| BG004 | 3 Units Per Crossover Infusion FDP-ACD x FFP | Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only |
| BG005 | 3 Units Per Crossover Infusion FFP x FDP-ACD | Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | Kg |
|
| Childbearing Potential | Female participants | Count of Participants | Participants |
|
| Rh Factor | Count of Participants | Participants |
|
| Blood Type | Count of Participants | Participants |
|
| History of any diseases and/or surgeries | Count of Participants | Participants |
|
Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection visit to allow re-infusion with 1 unit of autologous FDP-ACD 270 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers |
| OG002 | 2 Units, Single Infusion FDP-CPD | Subjects are to have sufficient plasma withdrawn during 2 separate WB collection visits to allow re-infusion with 2 units of autologous FDP-CPD 540 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers |
| OG003 | 2 Units, Single Infusion FDP-ACD | Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection to allow re-infusion with 2 units of autologous FDP-ACD 540 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers |
| OG004 | 3 Units Per Crossover Infusion FDP-ACD x FFP | Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only |
| OG005 | 3 Units Per Crossover Infusion FFP x FDP-ACD | Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only |
|
|
| Secondary | Number of Participants With Treatment-emergent Adverse Events | Assess the safety and tolerability of a fixed-dose infusion of 3 FDP units in comparison to infusion with the same dose of autologous Fresh Frozen Plasma (FFP) in normal healthy subjects by evaluating vital signs and laboratory tests | Posted | Count of Participants | Participants | Follow-up assessments on days 2, 8, 16, 22, 43, and telephone assessments on days 3, 4, 17, and 18 |
|
|
|
| Secondary | Number of Participants With Significant Changes in Specific Coagulation Values | Determine if the changes in specific coagulation values are similar with clinically meaningful levels pre and post infusion in the different arm groups by evaluating laboratory tests. Blood thrombin, Coombs direct test, Fibrin D dimer, and Thrombin-antithrombin III levels are determined through a blood test to check if your blood is clotting normally. Positive tests or any values below or above the normal reference range is considered abnormal. | Posted | Count of Participants | Participants | For cohorts 1 and 2, follow-up assessments on days 2, 8 and 29. For cohort 3, follow-up assessments on days 2, 8, 16, 22, and 43. |
|
|
|
| Secondary | Number of Participants With Significant Changes in Specific Hematology Values | Determine if the changes in specific hematology values are similar with clinically meaningful levels pre and post infusion in the different arm groups by evaluating laboratory tests. The specific hematology values are determined through a blood test. Any values below or above the normal reference range is considered abnormal. | Posted | Count of Participants | Participants | For cohorts 1 and 2, follow-up assessments on days 2, 8 and 29. For cohort 3, follow-up assessments on days 2, 8, 16, 22, and 43. |
|
|
|
| Secondary | Number of Participants With Significant Changes in Specific Chemistry Values | Determine if the changes in specific chemistry values are similar with clinically meaningful levels pre and post infusion in the different arm groups by evaluating laboratory tests. Glucose levels and liver function levels, ALT and AST, are determined through a blood test. Any values below or above the normal reference range is considered abnormal. | Posted | Count of Participants | Participants | For cohorts 1 and 2, follow-up assessments on days 2, 8 and 29. For cohort 3, follow-up assessments on days 2, 8, 16, 22, and 43. |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 2 |
| 4 |
| EG001 | 1 Unit, Single Infusion FDP-ACD | Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection visit to allow re-infusion with 1 unit of autologous FDP-ACD 270 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers | 0 | 4 | 0 | 4 | 2 | 4 |
| EG002 | 2 Units, Single Infusion FDP-CPD | Subjects are to have sufficient plasma withdrawn during 2 separate WB collection visits to allow re-infusion with 2 units of autologous FDP-CPD 540 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers | 0 | 4 | 0 | 4 | 0 | 4 |
| EG003 | 2 Units, Single Infusion FDP-ACD | Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection to allow re-infusion with 2 units of autologous FDP-ACD 540 mL Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers | 0 | 4 | 0 | 4 | 0 | 4 |
| EG004 | 3 Units Per Crossover Infusion FDP-ACD x FFP | Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only | 0 | 4 | 0 | 4 | 4 | 4 |
| EG005 | 3 Units Per Crossover Infusion FFP x FDP-ACD | Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits. 810 mL each infusion Autologous Freeze Dried Plasma (FDP): Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers Fresh Frozen Plasma (FFP): Controlled FFP in cohort 3 only | 0 | 4 | 0 | 4 | 1 | 4 |
| Temperature regulation disorder | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Coombs direct test positive | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Glycosuria | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Blood thrombin increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Thrombin-antithrombin III complex increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Fibrin D dimer increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| No |
|
| Negative |
|
| B |
|
| AB |
|
| O |
|
| No |
|
| Coombs direct test positive |
|
| Fibrin D dimer increased |
|
| Thrombin-antithrombin III increased |
|
| AST increased |
|
| Glucose increased |
|