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| ID | Type | Description | Link |
|---|---|---|---|
| CPP1-05 | Other Identifier | Army |
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This study is to evaluate the safety of intravenous (IV) infusion of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) in participants with World Health Organization (WHO) Grade 2 bleed in spite of receiving a transfusion of liquid stored platelets (LSP) in the past 48 hours by collecting adverse events (AEs) and by evaluating coagulation-related parameters to assess the evidence of any thrombotic events after CPP or LSP transfusion.
After determining eligibility for study participation, 4 sequential cohorts of subjects will receive escalating doses of CPP (Test) or 1 unit of LSP (Control) randomized 6:1 within each cohort. Each sequential cohort will receive the following transfusions starting with the first cohort: 0.5, 1, 2, and 3 units of CPP with an additional single subject in each cohort who will receive 1 unit of LSP for a total of 28 subjects. Assignment to Test and Control platelets for subjects in each cohort will be centrally randomized using an interactive web response system (IWRS). Following the study transfusion, subjects are followed for evidence of transfusion reactions, thrombotic events, other AEs, coagulation-related parameters, and platelet efficacy endpoints. CPP or LSP will be transfused into a patient according to the randomized product and dose assignment within the cohort. Following the transfusion, subjects are followed for the remainder of Study Day 1 and on Study Day 2 for AEs and tested for coagulation markers including fibrinogen, D-dimer, prothrombin fragments 1 + 2 (F 1+2), thrombin antithrombin (TAT), anti-thrombin (AT), prothrombin time (PT), activated partial thromboplastin time (aPTT), thrombin generation testing (TGT) results, thromboelastography (TEG) results, and other potential complications of platelet transfusion such as transfusion reactions and thrombotic events including assessment of vital signs (blood pressure, heart rate, respiration rate, and pulse oximetry). A subject is considered to have completed the study for safety evaluation for dose escalation, if he/she receives a study infusion and completed study-related Day 3 procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 with 0.5 units of CPP | Experimental | A single 30 to 60 minute intravenous (IV) infusion of 0.5 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) |
|
| Cohort 1 with 1 unit of LSP | Active Comparator | A single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP) |
|
| Cohort 2 with 1 unit of CPP | Experimental | A single 30 to 60 minute intravenous (IV) infusion of 1 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) |
|
| Cohort 2 with 1 unit of LSP | Active Comparator | A single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP) |
|
| Cohort 3 with 2 units of CPP | Experimental | A single 30 to 60 minute intravenous (IV) infusion of 2 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) |
|
| Cohort 3 with 1 unit of LSP |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPP | Biological | One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) by Level of Severity | Clinical laboratory [chemistry (serum creatinine, lactate dehydrogenase (LDH), and troponin, and hematology (hemoglobin and hematocrit)] parameters, physical examination findings, electrocardiogram (ECG)] and vital sign AEs summarized by severity. | day of thru 6 days after transfusion |
| Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Number of subjects who experienced AEs at specific levels of severity. Clinical laboratory [chemistry (serum creatinine, lactate dehydrogenase (LDH), and troponin, and hematology (hemoglobin and hematocrit)] parameters, physical examination findings, electrocardiogram (ECG)] and vital signs were evaluated. | day of thru 6 days after transfusion |
| Number of Subject With Thrombotic Events | Subjects with any signs or symptoms of thrombotic events. | 6 days after transfusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Corrected Count Increments (CCI) | Corrected Count Increments Expressed in units of mm^2/(µL*10¹¹ platelets) (CCI) in the 6 hour period after the study platelet transfusion and on Day 2 (approximately 24 hours after the study platelet transfusion) | Day 1 up to 6 hrs after transfusion and Day 2 approx 24 hrs after transfusion |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sherrill J Slichter, MD | Bloodworks | Principal Investigator |
| Terry B Gernsheimer, MD | University of Washington, Division of Hematology | Principal Investigator |
| Zbigniew Szczepiorkowski, MD, PhD | Center for Transfusion Medicine Research, Lebanon, NH | Principal Investigator |
| Jose A Cancelas-Perez, MD, PhD | Hoxworth Blood Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States | ||
| Hoxworth Blood Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30204953 | Derived | Slichter SJ, Dumont LJ, Cancelas JA, Jones M, Gernsheimer TB, Szczepiorkowski ZM, Dunbar NM, Prakash G, Medlin S, Rugg N, Kinne B, Macdonald VW, Housler G, Valiyaveettil M, Hmel P, Ransom JH. Safety and efficacy of cryopreserved platelets in bleeding patients with thrombocytopenia. Transfusion. 2018 Sep;58(9):2129-2138. doi: 10.1111/trf.14780. |
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Patient 29 was randomized to receive 0.5 Units of CPP but inadvertently received 1 Unit. This patient's data was analyzed with the 1 Unit CPP group.
Patients who were admitted to the site's medical center and undergoing treatment for a hematologic malignancy were potentially eligible for the study. Potential study subjects were recruited by preliminary medical chart review against the study eligibility criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 With 0.5 Units of CPP | A single 30 to 60 minute intravenous (IV) infusion of 0.5 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C. |
| FG001 | Cohort 2 With 1 Unit of CPP | A single 30 to 60 minute intravenous (IV) infusion of 1 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C. |
| FG002 | Cohort 3 With 2 Units of CPP | A single 30 to 60 minute intravenous (IV) infusion of 2 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C. |
| FG003 | Cohort 4 With 3 Units of CPP | A single 30 to 60 minute intravenous (IV) infusion of 3 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C. |
| FG004 | 1 Unit of LSP | A single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patient 29 was randomized to receive 0.5 Units of CPP but inadvertently received 1 Unit. This patient's data was analyzed with the 1 Unit CPP group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 With 0.5 Units of CPP | A single 30 to 60 minute intravenous (IV) infusion of 0.5 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C. |
| 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 | Adverse Events (AEs) by Level of Severity | Clinical laboratory [chemistry (serum creatinine, lactate dehydrogenase (LDH), and troponin, and hematology (hemoglobin and hematocrit)] parameters, physical examination findings, electrocardiogram (ECG)] and vital sign AEs summarized by severity. | Patient 29 was randomized to receive 0.5 Units of CPP but inadvertently received 1 Unit. This patient's data was analyzed with the 1 Unit CPP group. | Posted | Number | adverse events | day of thru 6 days after transfusion |
|
Day of transfusion thru 6 days after transfusion
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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 | Cohort 1 With 0.5 Units of CPP | A single 30 to 60 minute intravenous (IV) infusion of 0.5 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adults respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sherrill Slichter | Pugent Sound Blood Center | 206-292-6541 | sjslichter@psbc.org |
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| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| C014896 | 6-chloro-2-(1-piperazinyl)pyrazine |
| D004121 | Dimethyl Sulfoxide |
| ID | Term |
|---|---|
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Active Comparator |
A single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP) |
|
| Cohort 4 with 3 units of CPP | Experimental | A single 30 to 60 minute intravenous (IV) infusion of 3 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) |
|
| Cohort 4 with 1 unit of LSP | Active Comparator | A single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP |
|
|
| LSP | Biological |
|
|
| Count Increment |
Count Increment expressed in units of platelets (x10^3 µL) (CI) |
| On Day 1 up to 6 hours after transfusion and on Day 2 approximately 24 hours after transfusion |
| Cincinnati |
| Ohio |
| 45267 |
| United States |
| Puget Sound Blood Center | Seattle | Washington | 98104 | United States |
| University of Washington, Division of Hematology | Seattle | Washington | 98195 | United States |
| BG001 |
| Cohort 2 With 1 Unit of CPP |
A single 30 to 60 minute intravenous (IV) infusion of 1 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C. |
| BG002 | Cohort 3 With 2 Units of CPP | A single 30 to 60 minute intravenous (IV) infusion of 2 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C. |
| BG003 | Cohort 4 With 3 Units of CPP | A single 30 to 60 minute intravenous (IV) infusion of 3 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C. |
| BG004 | 1 Unit of LSP | A single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP) |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Patient 29 was randomized to receive 0.5 Units of CPP but inadvertently received 1 Unit. This patient's data was analyzed with the 1Unit CPP group. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline Weight (kg) | Mean | Standard Deviation | kg |
|
| Baseline Height (cm) | Mean | Standard Deviation | cm |
|
| OG001 | Cohort 2 With 1 Unit of CPP | A single 30 to 60 minute intravenous (IV) infusion of 1 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C. |
| OG002 | Cohort 3 With 2 Units of CPP | A single 30 to 60 minute intravenous (IV) infusion of 2 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C. |
| OG003 | Cohort 4 With 3 Units of CPP | A single 30 to 60 minute intravenous (IV) infusion of 3 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C. |
| OG004 | 1 Unit of LSP | A single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP) |
|
|
| Primary | Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity | Number of subjects who experienced AEs at specific levels of severity. Clinical laboratory [chemistry (serum creatinine, lactate dehydrogenase (LDH), and troponin, and hematology (hemoglobin and hematocrit)] parameters, physical examination findings, electrocardiogram (ECG)] and vital signs were evaluated. | Patient 29 was randomized to receive 0.5 Units of CPP but inadvertently received 1 Unit. This patient's data was analyzed with the 1 Unit CPP group. | Posted | Count of Participants | Participants | day of thru 6 days after transfusion |
|
|
|
| Primary | Number of Subject With Thrombotic Events | Subjects with any signs or symptoms of thrombotic events. | Posted | Count of Participants | Participants | 6 days after transfusion |
|
|
|
| Other Pre-specified | Corrected Count Increments (CCI) | Corrected Count Increments Expressed in units of mm^2/(µL*10¹¹ platelets) (CCI) in the 6 hour period after the study platelet transfusion and on Day 2 (approximately 24 hours after the study platelet transfusion) | Posted | Mean | Standard Deviation | mm^2/(μL*1011 platelets) | Day 1 up to 6 hrs after transfusion and Day 2 approx 24 hrs after transfusion |
|
|
|
| Other Pre-specified | Count Increment | Count Increment expressed in units of platelets (x10^3 µL) (CI) | Posted | Mean | Standard Deviation | platelets*10^3 µL | On Day 1 up to 6 hours after transfusion and on Day 2 approximately 24 hours after transfusion |
|
|
|
| 1 |
| 5 |
| 1 |
| 5 |
| 4 |
| 5 |
| EG001 | Cohort 2 With 1 Unit of CPP | A single 30 to 60 minute intravenous (IV) infusion of 1 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C. | 1 | 7 | 2 | 7 | 6 | 7 |
| EG002 | Cohort 3 With 2 Units of CPP | A single 30 to 60 minute intravenous (IV) infusion of 2 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG003 | Cohort 4 With 3 Units of CPP | A single 30 to 60 minute intravenous (IV) infusion of 3 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) CPP: One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C. | 1 | 6 | 2 | 6 | 5 | 6 |
| EG004 | 1 Unit of LSP | A single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP) | 0 | 4 | 0 | 4 | 1 | 4 |
| Cardiac arrest | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Prolonged QT interval | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Sepsis with gram negative rod bacteremia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Stroke | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Worsening lung infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Worsening sepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Affect lability | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Bacterial sepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Belligerence | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cardiac murmur | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Electocardiogram abnormal | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Electrocardiogram T wave abnormal | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Haemolysis | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Oedema peripheral | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Respiratory rate increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Scrotal eodema | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Skin odor abnormal | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Troponin increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Unresponsive to stimuli | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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| Total Patients with any AE |
|
| Total Patients with Mild AEs |
|
| Total Patients with Moderate AEs |
|
| Total Patients with Severe AEss |
|
| Total Patients with Life-threatening or Fatal AEs |
|
| Related to Investigational Product |
|
| CII: Day 2 |
|
| Day 2 |
|