Trial Outcomes & Findings for Efficacy of Mirasol-treated Apheresis Platelets in Patients With Hypoproliferative Thrombocytopenia (NCT NCT02964325)
NCT ID: NCT02964325
Last Updated: 2021-08-19
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
422 participants
Primary outcome timeframe
From the first post-randomization platelet transfusion through 28 days following the first transfusion.
Results posted on
2021-08-19
Participant Flow
Recruitment occurred at 11 hospital sites within the US. Enrollment occurred between 05 MAY 2017 and 07 APR 2020.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
164
|
166
|
|
Overall Study
Full Analysis Set
|
164
|
166
|
|
Overall Study
Modified Intent-to-Treat
|
145
|
152
|
|
Overall Study
Safety Set
|
141
|
161
|
|
Overall Study
COMPLETED
|
143
|
143
|
|
Overall Study
NOT COMPLETED
|
21
|
23
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Physician Decision
|
5
|
4
|
|
Overall Study
Death
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Did not require PLT transfusion, had HLA positive
|
10
|
12
|
Baseline Characteristics
Efficacy of Mirasol-treated Apheresis Platelets in Patients With Hypoproliferative Thrombocytopenia
Baseline characteristics by cohort
| Measure |
MIRASOL
n=141 Participants
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.
|
CONTROL
n=161 Participants
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.
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
94 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
41 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 16.32 • n=5 Participants
|
54.1 years
STANDARD_DEVIATION 18.24 • n=7 Participants
|
54.4 years
STANDARD_DEVIATION 17.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
130 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
277 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
120 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
257 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
141 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
302 Participants
n=5 Participants
|
|
Height (cm)
|
170.29 centimeters
STANDARD_DEVIATION 15.039 • n=5 Participants
|
167.88 centimeters
STANDARD_DEVIATION 18.472 • n=7 Participants
|
169.01 centimeters
STANDARD_DEVIATION 16.972 • n=5 Participants
|
|
Weight (kg)
|
86.96 kilograms
STANDARD_DEVIATION 23.876 • n=5 Participants
|
84.95 kilograms
STANDARD_DEVIATION 25.400 • n=7 Participants
|
85.89 kilograms
STANDARD_DEVIATION 24.680 • n=5 Participants
|
|
Body Surface Area (BSA)
|
1.975 square meters
STANDARD_DEVIATION 0.3157 • n=5 Participants
|
1.934 square meters
STANDARD_DEVIATION 0.3613 • n=7 Participants
|
1.953 square meters
STANDARD_DEVIATION 0.3408 • n=5 Participants
|
PRIMARY outcome
Timeframe: From the first post-randomization platelet transfusion through 28 days following the first transfusion.Population: 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.
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.
Outcome measures
| Measure |
MIRASOL
n=145 Participants
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.
|
CONTROL
n=152 Participants
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.
|
|---|---|---|
|
Days of ≥ Grade 2 Bleeding
|
1.7 Days
Standard Deviation 4.05
|
0.6 Days
Standard Deviation 1.51
|
SECONDARY outcome
Timeframe: HLA antibodies were measured at Baseline and Days 14, 28, and 56.Population: 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.
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).
Outcome measures
| Measure |
MIRASOL
n=136 Participants
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.
|
CONTROL
n=141 Participants
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.
|
|---|---|---|
|
Number and Percentage of Subjects With Human Leukocyte Antigen (HLA) Alloimmunization
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From the first post-randomization platelet transfusion through 28 days following the first transfusion.Population: 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.
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
Outcome measures
| Measure |
MIRASOL
n=145 Participants
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.
|
CONTROL
n=152 Participants
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.
|
|---|---|---|
|
Number and Percentage of Subjects With ≥ Grade 2 Bleeding
|
58 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: From the first post-randomization platelet transfusion through 28 days following the first transfusion.Population: 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.
The time to first ≥ Grade 2 bleeding was analyzed using a log-rank test comparing survival curves stratified by treatment group.
Outcome measures
| Measure |
MIRASOL
n=145 Participants
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.
|
CONTROL
n=152 Participants
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.
|
|---|---|---|
|
Number and Percentage of Subjects at the First Timepoint of ≥ Grade 2 Bleeding
Day 4
|
115 Participants
|
128 Participants
|
|
Number and Percentage of Subjects at the First Timepoint of ≥ Grade 2 Bleeding
Day 8
|
92 Participants
|
110 Participants
|
|
Number and Percentage of Subjects at the First Timepoint of ≥ Grade 2 Bleeding
Day 12
|
72 Participants
|
85 Participants
|
|
Number and Percentage of Subjects at the First Timepoint of ≥ Grade 2 Bleeding
Day 16
|
33 Participants
|
48 Participants
|
|
Number and Percentage of Subjects at the First Timepoint of ≥ Grade 2 Bleeding
Day 20
|
11 Participants
|
27 Participants
|
|
Number and Percentage of Subjects at the First Timepoint of ≥ Grade 2 Bleeding
Day 24
|
5 Participants
|
13 Participants
|
|
Number and Percentage of Subjects at the First Timepoint of ≥ Grade 2 Bleeding
Day 28
|
4 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: From the first post-randomization platelet transfusion through 28 days following the first transfusion.Population: 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.
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).
Outcome measures
| Measure |
MIRASOL
n=145 Participants
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.
|
CONTROL
n=152 Participants
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.
|
|---|---|---|
|
Number and Percentage of Subjects With ≥ Grade 3 Bleeding
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From the first post-randomization platelet transfusion through 28 days following the first transfusion.Population: 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.
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.
Outcome measures
| Measure |
MIRASOL
n=145 Participants
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.
|
CONTROL
n=152 Participants
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.
|
|---|---|---|
|
Number and Percentage of Subjects With PLT Refractoriness
|
41 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Initial post-randomization platelet transfusion through high Class I HLA development.Population: 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.
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.
Outcome measures
| Measure |
MIRASOL
n=136 Participants
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.
|
CONTROL
n=141 Participants
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.
|
|---|---|---|
|
Number and Percentage of Subjects With Immune Platelet Refractoriness
|
1 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initial post-randomization PLT transfusion through 72 hours following the last per protocol PLT transfusion.Population: 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.
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
Outcome measures
| Measure |
MIRASOL
n=141 Participants
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.
|
CONTROL
n=161 Participants
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.
|
|---|---|---|
|
Number and Percentage of Subjects With Unanticipated Adverse Device Effects (UADEs)
Blood and Lymphatic System Disorders/ Febrile Neutropenia
|
1 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With Unanticipated Adverse Device Effects (UADEs)
No UADEs
|
140 Participants
|
161 Participants
|
Adverse Events
MIRASOL
Serious events: 22 serious events
Other events: 97 other events
Deaths: 1 deaths
CONTROL
Serious events: 33 serious events
Other events: 100 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
MIRASOL
n=141 participants at risk
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.
|
CONTROL
n=161 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.8%
4/141 • Number of events 4 • 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.
|
6.8%
11/161 • Number of events 12 • 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.
|
|
Infections and infestations
Septic Shock
|
1.4%
2/141 • Number of events 2 • 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.
|
1.2%
2/161 • Number of events 3 • 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.
|
|
Infections and infestations
Streptococcal bacteremia
|
1.4%
2/141 • Number of events 2 • 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.
|
1.2%
2/161 • Number of events 2 • 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.
|
|
Infections and infestations
Bacteraemia
|
2.1%
3/141 • Number of events 3 • 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.
|
0.00%
0/161 • 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.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.71%
1/141 • Number of events 1 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Infections and infestations
Stomatococcal infection
|
1.4%
2/141 • Number of events 2 • 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.
|
0.00%
0/161 • 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.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.71%
1/141 • Number of events 1 • 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.
|
0.00%
0/161 • 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.
|
|
Infections and infestations
Candida infection
|
0.71%
1/141 • Number of events 1 • 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.
|
0.00%
0/161 • 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.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/141 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/141 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Infections and infestations
Cystitis viral
|
0.71%
1/141 • Number of events 1 • 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.
|
0.00%
0/161 • 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.
|
|
Infections and infestations
Device related infection
|
0.00%
0/141 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/141 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.71%
1/141 • Number of events 1 • 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.
|
0.00%
0/161 • 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.
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/141 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Infections and infestations
Human herpesvirus 6 infection
|
0.71%
1/141 • Number of events 1 • 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.
|
0.00%
0/161 • 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.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/141 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.71%
1/141 • Number of events 1 • 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.
|
0.00%
0/161 • 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.
|
|
Infections and infestations
Septic arthritis staphylococcal
|
0.00%
0/141 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Vascular disorders
Hypotension
|
2.1%
3/141 • Number of events 3 • 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.
|
1.2%
2/161 • Number of events 2 • 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.
|
|
Vascular disorders
Deep vein thrombosis
|
0.71%
1/141 • Number of events 1 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Vascular disorders
Embolism
|
0.71%
1/141 • Number of events 1 • 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.
|
0.00%
0/161 • 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.
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.00%
0/141 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
Delayed engraftment
|
0.00%
0/141 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
Febrile nonhaemolytic transfusion reaction
|
0.71%
1/141 • Number of events 1 • 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.
|
0.00%
0/161 • 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.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/141 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
Transfusion-associated dyspnoea
|
0.00%
0/141 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
Transfusion-related circulatory overload
|
0.00%
0/141 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.00%
0/141 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/141 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.00%
0/141 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Cardiac disorders
Sinus tachycardia
|
0.71%
1/141 • Number of events 1 • 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.
|
0.00%
0/161 • 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.
|
|
Cardiac disorders
Tachycardia
|
0.71%
1/141 • Number of events 1 • 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.
|
0.00%
0/161 • 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.
|
|
General disorders
Pyrexia
|
0.00%
0/141 • 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.
|
2.5%
4/161 • Number of events 4 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/141 • 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.
|
1.2%
2/161 • Number of events 3 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.71%
1/141 • Number of events 1 • 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.
|
0.00%
0/161 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/141 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.71%
1/141 • Number of events 1 • 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.
|
0.00%
0/161 • 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.
|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
0.71%
1/141 • Number of events 1 • 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.
|
0.00%
0/161 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/141 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Immune system disorders
Cytokine release syndrome
|
0.71%
1/141 • Number of events 1 • 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.
|
0.00%
0/161 • 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.
|
|
Immune system disorders
Engraftment syndrome
|
0.00%
0/141 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Immune system disorders
Graft versus host disease in gastrointestinal tract
|
0.00%
0/141 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.71%
1/141 • Number of events 1 • 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.
|
0.00%
0/161 • 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.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/141 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Nervous system disorders
Syncope
|
0.00%
0/141 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.71%
1/141 • Number of events 1 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/141 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Renal and urinary disorders
Urinary retention
|
0.71%
1/141 • Number of events 1 • 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.
|
0.00%
0/161 • 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.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/141 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/141 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Hepatobiliary disorders
Venoocclusive liver disease
|
0.00%
0/141 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Psychiatric disorders
Mental status changes
|
1.4%
2/141 • Number of events 2 • 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.
|
0.00%
0/161 • 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.
|
|
Investigations
Blood culture positive
|
0.71%
1/141 • Number of events 1 • 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.
|
0.00%
0/161 • 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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/141 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.71%
1/141 • Number of events 1 • 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.
|
0.62%
1/161 • Number of events 1 • 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.
|
Other adverse events
| Measure |
MIRASOL
n=141 participants at risk
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.
|
CONTROL
n=161 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
14.9%
21/141 • Number of events 21 • 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.
|
21.7%
35/161 • Number of events 35 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
13.5%
19/141 • Number of events 19 • 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.
|
8.7%
14/161 • Number of events 14 • 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.
|
|
Gastrointestinal disorders
Nausea
|
8.5%
12/141 • Number of events 12 • 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.
|
5.0%
8/161 • Number of events 8 • 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.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
6/141 • Number of events 6 • 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.
|
6.8%
11/161 • Number of events 11 • 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.
|
|
Gastrointestinal disorders
Stomatitis
|
7.8%
11/141 • Number of events 11 • 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.
|
3.7%
6/161 • Number of events 6 • 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.
|
|
General disorders
Pyrexia
|
13.5%
19/141 • Number of events 20 • 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.
|
9.9%
16/161 • Number of events 17 • 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.
|
|
General disorders
Mucosal inflammation
|
10.6%
15/141 • Number of events 15 • 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.
|
11.8%
19/161 • Number of events 19 • 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.
|
|
General disorders
Oedema peripheral
|
10.6%
15/141 • Number of events 18 • 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.
|
8.1%
13/161 • Number of events 14 • 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.
|
|
General disorders
Fatigue
|
9.2%
13/141 • Number of events 13 • 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.
|
5.6%
9/161 • Number of events 9 • 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.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
17.0%
24/141 • Number of events 27 • 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.
|
10.6%
17/161 • Number of events 17 • 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.
|
|
Blood and lymphatic system disorders
Anaemia
|
8.5%
12/141 • Number of events 12 • 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.
|
6.8%
11/161 • Number of events 11 • 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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.9%
14/141 • Number of events 15 • 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.
|
12.4%
20/161 • Number of events 20 • 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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.7%
8/141 • Number of events 8 • 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.
|
5.0%
8/161 • Number of events 8 • 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.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.7%
8/141 • Number of events 8 • 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.
|
5.0%
8/161 • Number of events 8 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.8%
11/141 • Number of events 11 • 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.
|
6.2%
10/161 • Number of events 10 • 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.
|
|
Nervous system disorders
Headache
|
6.4%
9/141 • Number of events 9 • 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.
|
6.8%
11/161 • Number of events 12 • 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.
|
|
Nervous system disorders
Dizziness
|
5.0%
7/141 • Number of events 8 • 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.
|
5.6%
9/161 • Number of events 11 • 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.
|
|
Injury, poisoning and procedural complications
Febrile nonhaemolytic transfusion reaction
|
5.0%
7/141 • Number of events 13 • 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.
|
5.0%
8/161 • Number of events 9 • 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.
|
Additional Information
Robert Cortes, Jr. MD
Terumo Blood and Cell Technologies
Phone: +1.303.231.4353
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60