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Based interim analysis results, Data Monitoring Committee did not believe the primary efficacy endpoint would be met. No patient safety concerns.
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| Name | Class |
|---|---|
| Biomedical Advanced Research and Development Authority | FED |
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This is a prospective, multi-center, controlled, randomized, non-inferiority study to evaluate the clinical effectiveness of Conventional versus Mirasol-treated apheresis platelets in subjects with hypoproliferative thrombocytopenia who are expected to have platelet count(s) ≤ 10,000/μL requiring ≥ 2 platelet transfusions.
Patients will be randomized 1:1 to Mirasol-treated platelets (test platelets) or to conventional, untreated platelets (control platelets). The blood centers will collect the apheresis donor platelets and supply the test platelets to the hospital sites for transfusion into patients. Hospital sites will order control platelets as per their normal process, from their standard vendor.
The target population for the MIPLATE study are patients with hematologic malignancies with hypoproliferative thrombocytopenia who are expected to have platelet (PLT) count(s) of ≤ 10,000/μL requiring ≥ 2 PLT transfusions.
The primary objective of MIPLATE is to determine if the hemostatic efficacy of Mirasol-treated plasma stored Trima Accel® Aph PLTs are non-inferior to Conventional plasma stored Aph PLTs in subjects with hypoproliferative thrombocytopenia requiring PLT transfusions. The secondary objectives include comparing other efficacy and safety endpoints between the treatment groups.
Subjects with hematologic malignancies with hypoproliferative thrombocytopenia are anticipated to experience a "transfusion episode" where they will require PLT transfusion support until bone marrow recovery. During this period all PLT transfusions required for a study subject will be given according to the subject's treatment allocation for 28 days after the initial PLT transfusion OR until transfusion independence (10 days without PLT transfusion) prior to Day 28.
Additionally, serum samples for HLA antibody testing will be collected on Days 14, 28 and 56.
At a minimum, the initial post-randomization prophylactic PLT transfusion will be initiated for a PLT count ≤ 10,000/µL. Thereafter, indications for PLT transfusions may be PLT count-related prophylaxis, intervention-related prophylaxis, or therapeutic (treatment of active bleeding) as determined by the treating physician(s). The indication(s) for the transfusion(s) will be captured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirasol platelets (MIR PLTs) | Experimental | Leukoreduced, Trima Accel® apheresis platelets stored in 100% plasma, pathogen reduced with the Mirasol® Pathogen Reduction Technology (PRT) System |
|
| Reference platelets (REF PLTs) | Active Comparator | Leukoreduced, apheresis platelets stored in 100% plasma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirasol platelets (MIR PLTs) | Device | The final product to be transfused to the subject will be leukoreduced (LR), apheresis (Aph) single-donor platelets (PLTs) at the standard therapeutic dose of 1 unit of Aph PLTs containing ≥ 3.0 × 1.0E11 PLTs. MIR PLTs will be treated with the Mirasol pathogen reduction technology system. |
| Measure | Description | Time Frame |
|---|---|---|
| Days of ≥ Grade 2 Bleeding | Number of days of Grade 2 or higher bleeding recorded from treatment start date through 28 days following the first transfusion, until transfusion independence (10 days without PLT transfusion) prior to Day 28, or study termination, whichever occurred first. Subjects who obtained transfusion independence prior to Day 28 were assumed to have zero bleeding events between the date of transfusion independence and Day 28. Observed and simulated data for off-protocol transfusion intervals were included. | From the first post-randomization platelet transfusion through 28 days following the first transfusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Subjects With Human Leukocyte Antigen (HLA) Alloimmunization | The outcome was the development of a new HLA Class I antibodies among subjects negative at baseline within each treatment group. Positivity for Class I HLA antibodies was determined by the 5 SD normalized background ratio cutoffs assay threshold (>59.2, LABScreen Mixed LSM12, One Lambda). | HLA antibodies were measured at Baseline and Days 14, 28, and 56. |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Subjects With Unanticipated Adverse Device Effects (UADEs) | UADEs are identified as treatment emergent adverse events reported by the investigator as serious, unanticipated, at least possibly related to study device or at least possibly related to treatment. UADEs were coded using Medical Dictionary for Regulatory Activities (MedDRA) Version 19.1 | From initial post-randomization PLT transfusion through 72 hours following the last per protocol PLT transfusion. |
Inclusion Criteria:
Weight > 10 kg (22 lbs)
Subject has a hematologic malignancy with hypoproliferative thrombocytopenia and is expected to have PLT count(s) ≤ 10,000/µL requiring ≥ 2 PLT transfusions
Laboratory results within 5 days prior to anticipated initiation of the first post randomization PLT transfusion:
Women of childbearing potential must have a negative pregnancy test and agree to practice a medically acceptable contraception regimen for the study duration. Women who are postmenopausal for at least 1 year (> 12 months since last menses) or are surgically sterilized do not require this test
IC from the subject or assent from the subject and consent from a parent or guardian, if the subject is < 18 years of age
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Cortes, MD | Terumo BCT | Study Director |
| Sherrill Slichter, MD | Bloodworks Northwest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| University of Florida Health Shands Hospital |
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Full Analysis Set (FAS) - all randomized subjects. Safety Set (SS) - randomized subjects who received at least 1 PLT transfusion post-randomization, independent of the outcome or successful completions of the procedure. Modified Intent-to-Treat (mITT) - all randomized subjects who had at least 1 study transfusion according to randomized study group. 422 subjects consented, 92 screen failed, 330 FAS, 28 received no transfusion, 302 SS, 5 received no transfusion per assigned group, 297 mITT.
Recruitment occurred at 11 hospital sites within the US. Enrollment occurred between 05 MAY 2017 and 07 APR 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | MIRASOL | Randomized to leukoreduced, Trima Accel® apheresis platelets stored in 100% plasma, pathogen reduced with the Mirasol® Pathogen Reduction Technology (PRT) System Mirasol platelets (MIR PLTs): The final product to be transfused to the subject will be leukoreduced (LR), apheresis (Aph) single-donor platelets (PLTs) at the standard therapeutic dose of 1 unit of Aph PLTs containing ≥ 3.0 × 1.0E11 PLTs. MIR PLTs will be treated with the Mirasol pathogen reduction technology system. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 30, 2019 | Feb 19, 2021 |
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Though this is not a blinded study, treatment assignment is obtained through electronic system and should not be shared those performing the primary outcome assessment or assessors of adverse events.
|
| Reference platelets (REF PLTs) | Device | The final product to be transfused to the subject will be LR-Aph single-donor PLTs at the standard therapeutic dose of 1 unit of Aph PLTs containing ≥ 3.0 × 1.0E11 PLTs. |
|
| Number and Percentage of Subjects With ≥ Grade 2 Bleeding | The number and percentage of subjects with at least 1 day of ≥ Grade 2 bleeding from Day 0 through Day 27 (or until transfusion independence was achieved) by treatment group | From the first post-randomization platelet transfusion through 28 days following the first transfusion. |
| Number and Percentage of Subjects at the First Timepoint of ≥ Grade 2 Bleeding | The time to first ≥ Grade 2 bleeding was analyzed using a log-rank test comparing survival curves stratified by treatment group. | From the first post-randomization platelet transfusion through 28 days following the first transfusion. |
| Number and Percentage of Subjects With ≥ Grade 3 Bleeding | The number and percentage of subjects with at least 1 day of ≥ Grade 3 bleeding from Day 0 through Day 27 (or until transfusion independence was achieved). | From the first post-randomization platelet transfusion through 28 days following the first transfusion. |
| Number and Percentage of Subjects With PLT Refractoriness | The number and percentage of subjects with PLT refractoriness defined as 2 sequential transfusions, each with corrected count increments (CCIs) < 5000 measured 1 hour post-transfusion. | From the first post-randomization platelet transfusion through 28 days following the first transfusion. |
| Number and Percentage of Subjects With Immune Platelet Refractoriness | The number and percentage of subjects with PLT refractoriness for each treatment group. Subjects were defined as immune PLT refractoriness based on 2 sequential transfusion episodes, each with CCIs < 5000 measured 1 hour post transfusion, and who also had a positive antibody test within 14 days before or after the onset of PLT refractoriness. | Initial post-randomization platelet transfusion through high Class I HLA development. |
| Gainesville |
| Florida |
| 32608 |
| United States |
| Emory University/Children's Hospital of Atlanta | Atlanta | Georgia | 30322 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| John Hopkins University School of Medicine/Johns Hopkins Kimmel Cancer Center | Baltimore | Maryland | 21231 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Robert Wood Johnson Medical School/RWJ University Hospital | New Brunswick | New Jersey | 08903 | United States |
| University of Washington Medical Center | Seattle | Washington | 98109 | United States |
| FG001 | CONTROL | Randomized to leukoreduced, apheresis platelets stored in 100% plasma Reference platelets (REF PLTs): The final product to be transfused to the subject will be LR-Aph single-donor PLTs at the standard therapeutic dose of 1 unit of Aph PLTs containing ≥ 3.0 × 1.0E11 PLTs. |
| Full Analysis Set | The Full Analysis Set (FAS) included all randomized subjects. Subjects were analyzed according to the treatment group to which they were assigned at randomization. |
|
| Modified Intent-to-Treat | The Modified Intent-to-Treat (mITT) Set included all randomized subjects who underwent at least 1 study transfusion post randomization according to the treatment group (MIRASOL or CONTROL) to which they were randomized. |
|
| Safety Set | The Safety Set (SS) included all randomized subjects who underwent at least 1 PLT transfusion post randomization, independent of the outcome or successful completion of the procedure. Subjects were analyzed according to the majority treatment (MIR PLTs or REF PLTs) received. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Safety Analysis Set was used for this analysis. Safety Set (SS) = randomized subjects who received at least 1 PLT transfusion post-randomization, independent of the outcome or successful completions of the procedure. Subjects were analyzed according to the majority treatment received.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MIRASOL | Randomized to leukoreduced, Trima Accel® apheresis platelets stored in 100% plasma, pathogen reduced with the Mirasol® Pathogen Reduction Technology (PRT) System Mirasol platelets (MIR PLTs): The final product to be transfused to the subject will be leukoreduced (LR), apheresis (Aph) single-donor platelets (PLTs) at the standard therapeutic dose of 1 unit of Aph PLTs containing ≥ 3.0 × 1.0E11 PLTs. MIR PLTs will be treated with the Mirasol pathogen reduction technology system. |
| BG001 | CONTROL | Randomized to leukoreduced, apheresis platelets stored in 100% plasma Reference platelets (REF PLTs): The final product to be transfused to the subject will be LR-Aph single-donor PLTs at the standard therapeutic dose of 1 unit of Aph PLTs containing ≥ 3.0 × 1.0E11 PLTs. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Height (cm) | Mean | Standard Deviation | centimeters |
| |||||||||||||||||
| Weight (kg) | Mean | Standard Deviation | kilograms |
| |||||||||||||||||
| Body Surface Area (BSA) | The Dubois formula was used to calculate body surface area (BSA). BSA (m2) = 0.007184 × Height (cm)0.725 × Weight (kg)0.425 | Mean | Standard Deviation | square meters |
|
| 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 | Days of ≥ Grade 2 Bleeding | Number of days of Grade 2 or higher bleeding recorded from treatment start date through 28 days following the first transfusion, until transfusion independence (10 days without PLT transfusion) prior to Day 28, or study termination, whichever occurred first. Subjects who obtained transfusion independence prior to Day 28 were assumed to have zero bleeding events between the date of transfusion independence and Day 28. Observed and simulated data for off-protocol transfusion intervals were included. | The Modified Intent-to-Treat Analysis Set was used for this analysis. Modified Intent-to-Treat Analysis Set = all randomized subjects who had at least 1 study transfusion according to randomized study group. | Posted | Mean | Standard Deviation | Days | From the first post-randomization platelet transfusion through 28 days following the first transfusion. |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number and Percentage of Subjects With Human Leukocyte Antigen (HLA) Alloimmunization | The outcome was the development of a new HLA Class I antibodies among subjects negative at baseline within each treatment group. Positivity for Class I HLA antibodies was determined by the 5 SD normalized background ratio cutoffs assay threshold (>59.2, LABScreen Mixed LSM12, One Lambda). | The Modified Intent-to-Treat Analysis Set was used for this analysis. Modified Intent-to-Treat Analysis Set = all randomized subjects who had at least 1 study transfusion according to randomized study group. Subjects who tested positive at the high assay threshold (5 SD normalized background ratio cutoffs >59.2, LABScreen Mixed LSM12, One Lambda) at Baseline were excluded from this analysis. | Posted | Count of Participants | Participants | HLA antibodies were measured at Baseline and Days 14, 28, and 56. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number and Percentage of Subjects With ≥ Grade 2 Bleeding | The number and percentage of subjects with at least 1 day of ≥ Grade 2 bleeding from Day 0 through Day 27 (or until transfusion independence was achieved) by treatment group | The Modified Intent-to-Treat Analysis Set was used for this analysis. Modified Intent-to-Treat Analysis Set = all randomized subjects who had at least 1 study transfusion according to randomized study group. | Posted | Count of Participants | Participants | From the first post-randomization platelet transfusion through 28 days following the first transfusion. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number and Percentage of Subjects at the First Timepoint of ≥ Grade 2 Bleeding | The time to first ≥ Grade 2 bleeding was analyzed using a log-rank test comparing survival curves stratified by treatment group. | The mITT Set was used for this analysis. Subjects that did not experience a ≥ Grade 2 bleed were censored at Day 27 or at date of transfusion independence (10th day without a PLT transfusion prior to last follow-up day or Day 27, whichever occurred earlier), where appropriate. Subjects that did not complete the study or were lost to follow-up were censored on the date of their last study visit in the treatment period. | Posted | Count of Participants | Participants | From the first post-randomization platelet transfusion through 28 days following the first transfusion. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number and Percentage of Subjects With ≥ Grade 3 Bleeding | The number and percentage of subjects with at least 1 day of ≥ Grade 3 bleeding from Day 0 through Day 27 (or until transfusion independence was achieved). | The Modified Intent-to-Treat Analysis Set was used for this analysis. Modified Intent-to-Treat Analysis Set = all randomized subjects who had at least 1 study transfusion according to randomized study group. | Posted | Count of Participants | Participants | From the first post-randomization platelet transfusion through 28 days following the first transfusion. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number and Percentage of Subjects With PLT Refractoriness | The number and percentage of subjects with PLT refractoriness defined as 2 sequential transfusions, each with corrected count increments (CCIs) < 5000 measured 1 hour post-transfusion. | The Modified Intent-to-Treat Analysis Set was used for this analysis. Modified Intent-to-Treat Analysis Set = all randomized subjects who had at least 1 study transfusion according to randomized study group. | Posted | Count of Participants | Participants | From the first post-randomization platelet transfusion through 28 days following the first transfusion. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number and Percentage of Subjects With Immune Platelet Refractoriness | The number and percentage of subjects with PLT refractoriness for each treatment group. Subjects were defined as immune PLT refractoriness based on 2 sequential transfusion episodes, each with CCIs < 5000 measured 1 hour post transfusion, and who also had a positive antibody test within 14 days before or after the onset of PLT refractoriness. | The Modified Intent-to-Treat Analysis Set was used for this analysis. Modified Intent-to-Treat Analysis Set = all randomized subjects who had at least 1 study transfusion according to randomized study group. | Posted | Count of Participants | Participants | Initial post-randomization platelet transfusion through high Class I HLA development. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number and Percentage of Subjects With Unanticipated Adverse Device Effects (UADEs) | UADEs are identified as treatment emergent adverse events reported by the investigator as serious, unanticipated, at least possibly related to study device or at least possibly related to treatment. UADEs were coded using Medical Dictionary for Regulatory Activities (MedDRA) Version 19.1 | The Safety Set was used for this analysis. Safety Set = randomized subjects who received at least 1 PLT transfusion post-randomization, independent of the outcome or successful completions of the procedure. | Posted | Count of Participants | Participants | From initial post-randomization PLT transfusion through 72 hours following the last per protocol PLT transfusion. |
|
Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) that occurred from initial post randomization platelet transfusion through seventy-two (72) hours following the transfusion end time of the last on-protocol PLT transfusion were reported. Deaths that occurred (including deaths due to bleeding) thirty days (30) following the transfusion end time of the last on-protocol PLT transfusion were reported.
Treatment Emergent definition: an event that first appears during treatment, which was absent before or which worsened relative to the pre-treatment state. Treatment emergent are those events that occur during or following the first post-randomization PLT transfusion. All TEAEs/TESAEs were followed until resolution, stabilization, or the end of the subject's study participation which occurred first.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MIRASOL | Randomized to leukoreduced, Trima Accel® apheresis platelets stored in 100% plasma, pathogen reduced with the Mirasol® Pathogen Reduction Technology (PRT) System Mirasol platelets (MIR PLTs): The final product to be transfused to the subject will be leukoreduced (LR), apheresis (Aph) single-donor platelets (PLTs) at the standard therapeutic dose of 1 unit of Aph PLTs containing ≥ 3.0 × 1.0E11 PLTs. MIR PLTs will be treated with the Mirasol pathogen reduction technology system. | 1 | 141 | 22 | 141 | 97 | 141 |
| EG001 | CONTROL | Randomized to leukoreduced, apheresis platelets stored in 100% plasma Reference platelets (REF PLTs): The final product to be transfused to the subject will be LR-Aph single-donor PLTs at the standard therapeutic dose of 1 unit of Aph PLTs containing ≥ 3.0 × 1.0E11 PLTs. | 3 | 161 | 33 | 161 | 100 | 161 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Streptococcal bacteremia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Stomatococcal infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Cystitis viral | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Human herpesvirus 6 infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Pseudomonal bacteraemia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Septic arthritis staphylococcal | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Allergic transfusion reaction | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Delayed engraftment | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Febrile nonhaemolytic transfusion reaction | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Transfusion-associated dyspnoea | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Transfusion-related circulatory overload | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Transplant failure | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Right ventricular dysfunction | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Diaphragmatic hernia | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Engraftment syndrome | Immune system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Graft versus host disease in gastrointestinal tract | Immune system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Venoocclusive liver disease | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Blood culture positive | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Febrile nonhaemolytic transfusion reaction | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
The clinical trial was terminated early on the recommendation of the Data Monitoring Committee and in agreement with the Clinical Trial Steering Committee and the Sponsor.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Cortes, Jr. MD | Terumo Blood and Cell Technologies | +1.303.231.4353 | Robert.Cortes@terumobct.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 2, 2020 | Feb 19, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
Not provided
Not provided
| >=65 years |
|
| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Missing |
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| Asian |
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| Other |
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| Non-Inferiority |
An NI analysis was carried out to assess the primary efficacy endpoint with the null hypothesis being the MIRASOL group is inferior to the CONTROL group and the alternative hypothesis being the MIRASOL group is non-inferior to the CONTROL group. In this study, the NI margin was 1.6. |
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