Trial Outcomes & Findings for Optimal Platelet Dose Strategy for Management of Thrombocytopenia (NCT NCT00128713)

Last Updated: 2015-10-28

Results Overview

Any Grade 2 (moderate) or higher grade bleeding, as determined by daily hemostatic assessment and documentation of any red blood cell transfusions to treat bleeding

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1351 participants

Primary outcome timeframe

From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)

Results posted on

2015-10-28

Participant Flow

Participant milestones

Participant milestones
Measure	Lower Dose Platelets Lower Dose Prophylactic Platelets (1.1 x 10\^11 per m\^2 Body Surface Area per transfusion, +/- 25%)	Medium Dose Platelets Medium Dose Prophylactic Platelets (2.2 x 10\^11 per m\^2 Body Surface Area per transfusion, +/- 25%)	Higher Dose Platelets Higher Dose Prophylactic Platelets (4.4 x 10\^11 per m\^2 Body Surface Area per transfusion, +/- 25%)
Overall Study STARTED	453	449	449
Overall Study COMPLETED	453	449	449
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Optimal Platelet Dose Strategy for Management of Thrombocytopenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lower Dose Platelets n=453 Participants Lower Dose Prophylactic Platelets (1.1 x 10\^11 per m\^2 Body Surface Area per transfusion, +/- 25%)	Medium Dose Platelets n=449 Participants Medium Dose Prophylactic Platelets (2.2 x 10\^11 per m\^2 Body Surface Area per transfusion, +/- 25%)	Higher Dose Platelets n=449 Participants Higher Dose Prophylactic Platelets (4.4 x 10\^11 per m\^2 Body Surface Area per transfusion, +/- 25%)	Total n=1351 Participants Total of all reporting groups
Age, Continuous	43.5 years STANDARD_DEVIATION 19.3 • n=5 Participants	44.7 years STANDARD_DEVIATION 19.3 • n=7 Participants	45.5 years STANDARD_DEVIATION 19.7 • n=5 Participants	44.6 years STANDARD_DEVIATION 19.4 • n=4 Participants
Age, Customized 0 - 17 years	67 participants n=5 Participants	68 participants n=7 Participants	64 participants n=5 Participants	199 participants n=4 Participants
Age, Customized 18 - 20 years	9 participants n=5 Participants	6 participants n=7 Participants	8 participants n=5 Participants	23 participants n=4 Participants
Age, Customized >=21 years	377 participants n=5 Participants	374 participants n=7 Participants	377 participants n=5 Participants	1128 participants n=4 Participants
Age, Customized Unknown/not reported	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Sex/Gender, Customized Female	189 participants n=5 Participants	176 participants n=7 Participants	169 participants n=5 Participants	534 participants n=4 Participants
Sex/Gender, Customized Male	264 participants n=5 Participants	272 participants n=7 Participants	280 participants n=5 Participants	816 participants n=4 Participants
Sex/Gender, Customized Unknown/not reported	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	19 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Black or African American	53 Participants n=5 Participants	37 Participants n=7 Participants	40 Participants n=5 Participants	130 Participants n=4 Participants
Race (NIH/OMB) White	362 Participants n=5 Participants	374 Participants n=7 Participants	378 Participants n=5 Participants	1114 Participants n=4 Participants
Race (NIH/OMB) More than one race	13 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	32 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants	20 Participants n=7 Participants	14 Participants n=5 Participants	46 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=5 Participants	19 Participants n=7 Participants	21 Participants n=5 Participants	58 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	433 Participants n=5 Participants	425 Participants n=7 Participants	423 Participants n=5 Participants	1281 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	12 Participants n=4 Participants
Region of Enrollment United States	453 participants n=5 Participants	449 participants n=7 Participants	449 participants n=5 Participants	1351 participants n=4 Participants
Treatment Regimen Autologous or syngeneic stem cell transplant	154 Participants n=5 Participants	149 Participants n=7 Participants	151 Participants n=5 Participants	454 Participants n=4 Participants
Treatment Regimen Allogeneic stem cell transplant	185 Participants n=5 Participants	185 Participants n=7 Participants	186 Participants n=5 Participants	556 Participants n=4 Participants
Treatment Regimen Chemotherapy for hematologic malignancy	111 Participants n=5 Participants	112 Participants n=7 Participants	110 Participants n=5 Participants	333 Participants n=4 Participants
Treatment Regimen Chemotherapy for solid tumor	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Body Surface Area	1.8 m^2 STANDARD_DEVIATION 0.4 • n=5 Participants	1.8 m^2 STANDARD_DEVIATION 0.4 • n=7 Participants	1.8 m^2 STANDARD_DEVIATION 0.4 • n=5 Participants	1.8 m^2 STANDARD_DEVIATION 0.4 • n=4 Participants
Height	165.5 cm STANDARD_DEVIATION 21.4 • n=5 Participants	164.0 cm STANDARD_DEVIATION 21.7 • n=7 Participants	166.2 cm STANDARD_DEVIATION 19.3 • n=5 Participants	165.2 cm STANDARD_DEVIATION 20.8 • n=4 Participants
Weight	77.4 kg STANDARD_DEVIATION 24.9 • n=5 Participants	75.0 kg STANDARD_DEVIATION 26.3 • n=7 Participants	76.0 kg STANDARD_DEVIATION 23.8 • n=5 Participants	76.1 kg STANDARD_DEVIATION 25.0 • n=4 Participants

PRIMARY outcome

Timeframe: From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)

Population: These analyses were done on an intention-to-treat basis. That is, patients were counted in the treatment arm to which they were randomly assigned, even if they actually received transfusions that were not according to their assigned dosing strategy.

Any Grade 2 (moderate) or higher grade bleeding, as determined by daily hemostatic assessment and documentation of any red blood cell transfusions to treat bleeding

Outcome measures

Outcome measures
Measure	Lower Dose Platelets n=446 Participants Lower Dose Prophylactic Platelets (1.1 x 10\^11 per m\^2 Body Surface Area per transfusion, +/- 25%)	Medium Dose Platelets n=435 Participants Medium Dose Prophylactic Platelets (2.2 x 10\^11 per m\^2 Body Surface Area per transfusion, +/- 25%)	Higher Dose Platelets n=434 Participants Higher Dose Prophylactic Platelets (4.4 x 10\^11 per m\^2 Body Surface Area per transfusion, +/- 25%)
At Least One Day With Grade 2 or Higher Bleeding Yes	304 participants	293 participants	299 participants
At Least One Day With Grade 2 or Higher Bleeding No	142 participants	142 participants	135 participants
At Least One Day With Grade 2 or Higher Bleeding Not Evaluable	7 participants	14 participants	15 participants

SECONDARY outcome

Population: Subjects with missing information and those that did not receive at least one platelet transfusion were excluded from the analysis.

Total number of platelets transfused, based on attempted dose, among subjects who have at least one platelet transfusion and no missing data on attempted doses.

Outcome measures

Outcome measures
Measure	Lower Dose Platelets n=357 Participants Lower Dose Prophylactic Platelets (1.1 x 10\^11 per m\^2 Body Surface Area per transfusion, +/- 25%)	Medium Dose Platelets n=387 Participants Medium Dose Prophylactic Platelets (2.2 x 10\^11 per m\^2 Body Surface Area per transfusion, +/- 25%)	Higher Dose Platelets n=395 Participants Higher Dose Prophylactic Platelets (4.4 x 10\^11 per m\^2 Body Surface Area per transfusion, +/- 25%)
Platelet Utilization	10.96 Number of platelets (x10^11) Interval 0.67 to 196.35	12.49 Number of platelets (x10^11) Interval 1.06 to 487.33	22.43 Number of platelets (x10^11) Interval 2.49 to 363.66

SECONDARY outcome

Population: Subjects with missing information and those that did not receive at least one platelet transfusion were excluded from the analysis.

Number of platelet transfusion episodes among subjects who have at least one platelet transfusion and no missing data on attempted doses.

Outcome measures

Outcome measures
Measure	Lower Dose Platelets n=357 Participants Lower Dose Prophylactic Platelets (1.1 x 10\^11 per m\^2 Body Surface Area per transfusion, +/- 25%)	Medium Dose Platelets n=387 Participants Medium Dose Prophylactic Platelets (2.2 x 10\^11 per m\^2 Body Surface Area per transfusion, +/- 25%)	Higher Dose Platelets n=395 Participants Higher Dose Prophylactic Platelets (4.4 x 10\^11 per m\^2 Body Surface Area per transfusion, +/- 25%)
Number of Platelet Transfusion Episodes	5 Number of platelet transfusion episodes Interval 1.0 to 58.0	3 Number of platelet transfusion episodes Interval 1.0 to 111.0	3 Number of platelet transfusion episodes Interval 1.0 to 44.0

SECONDARY outcome

Population: Analysis not performed; no applicable bleeding severity scale validated and published by end of PLADO Study

No suitable scale was identified, so no analyses for this outcome were carried out

Outcome measures

Outcome data not reported

SECONDARY outcome

Population: The analysis was done as intention to treat. Subjects for which highest grade of bleeding could not be determined (non-evaluable) were excluded.

Highest grade of bleeding during time on study using Platelet Dose Trial modification of World Health Organization Bleeding Scale. Grades 0-1 (no or minimal bleeding), 2 (moderate bleeding), 3 (bleeding generally requiring red cell transfusion), 4 (severe bleeding)

Outcome measures

Outcome measures
Measure	Lower Dose Platelets n=435 Participants Lower Dose Prophylactic Platelets (1.1 x 10\^11 per m\^2 Body Surface Area per transfusion, +/- 25%)	Medium Dose Platelets n=423 Participants Medium Dose Prophylactic Platelets (2.2 x 10\^11 per m\^2 Body Surface Area per transfusion, +/- 25%)	Higher Dose Platelets n=424 Participants Higher Dose Prophylactic Platelets (4.4 x 10\^11 per m\^2 Body Surface Area per transfusion, +/- 25%)
Highest Grade of Bleeding While on Study Grade 0 or 1 (no bleeding or minimal bleeding)	142 participants	142 participants	135 participants
Highest Grade of Bleeding While on Study Grade 2 (moderate bleeding)	245 participants	244 participants	249 participants
Highest Grade of Bleeding While on Study Grade 3 (bleeding generally requiring RBC's)	36 participants	27 participants	33 participants
Highest Grade of Bleeding While on Study Grade 4 (severe bleeding)	12 participants	10 participants	7 participants
Highest Grade of Bleeding While on Study Not Evaluable	18 participants	26 participants	25 participants

Adverse Events

Lower Dose Platelets

Serious events: 38 serious events

Other events: 197 other events

Deaths: 0 deaths

Medium Dose Platelets

Serious events: 27 serious events

Other events: 182 other events

Deaths: 0 deaths

Higher Dose Platelets

Serious events: 36 serious events

Other events: 203 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Lower Dose Platelets n=453 participants at risk Lower Dose Prophylactic Platelets (1.1 x 10\^11 per m\^2 Body Surface Area per transfusion, +/- 25%)	Medium Dose Platelets n=449 participants at risk Medium Dose Prophylactic Platelets (2.2 x 10\^11 per m\^2 Body Surface Area per transfusion, +/- 25%)	Higher Dose Platelets n=449 participants at risk Higher Dose Prophylactic Platelets (4.4 x 10\^11 per m\^2 Body Surface Area per transfusion, +/- 25%)
Immune system disorders Allergic Reaction/Hypersensitivity	8.2% 37/453 • Number of events 50 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.	10.2% 46/449 • Number of events 60 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.	12.2% 55/449 • Number of events 82 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.
Cardiac disorders Sinus Bradycardia	0.88% 4/453 • Number of events 6 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.	1.1% 5/449 • Number of events 6 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.	1.3% 6/449 • Number of events 7 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.
Cardiac disorders Sinus Tachycardia	9.5% 43/453 • Number of events 91 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.	9.1% 41/449 • Number of events 86 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.	7.8% 35/449 • Number of events 54 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.
General disorders Hypertension	8.6% 39/453 • Number of events 81 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.	7.6% 34/449 • Number of events 61 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.	10.2% 46/449 • Number of events 75 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.
General disorders Hypotension	7.1% 32/453 • Number of events 52 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.	5.1% 23/449 • Number of events 28 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.	5.6% 25/449 • Number of events 36 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.8% 17/453 • Number of events 22 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.	4.5% 20/449 • Number of events 30 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.	4.0% 18/449 • Number of events 22 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.9% 13/453 • Number of events 15 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.	3.3% 15/449 • Number of events 19 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.	3.1% 14/449 • Number of events 18 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.
Respiratory, thoracic and mediastinal disorders Wheezing	1.5% 7/453 • Number of events 9 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.	0.45% 2/449 • Number of events 3 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.	2.9% 13/449 • Number of events 16 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.
Respiratory, thoracic and mediastinal disorders Cough	0.66% 3/453 • Number of events 3 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.	0.89% 4/449 • Number of events 4 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.	1.6% 7/449 • Number of events 8 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.
Blood and lymphatic system disorders Hemolysis	0.44% 2/453 • Number of events 2 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.	0.22% 1/449 • Number of events 1 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.	0.45% 2/449 • Number of events 3 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.
General disorders Rigors, chills	8.2% 37/453 • Number of events 55 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.	9.4% 42/449 • Number of events 55 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.	10.9% 49/449 • Number of events 72 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.
General disorders Fever	33.8% 153/453 • Number of events 425 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.	29.6% 133/449 • Number of events 333 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.	31.8% 143/449 • Number of events 358 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.
Infections and infestations Infection	0.88% 4/453 • Number of events 6 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.	0.89% 4/449 • Number of events 4 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.	1.3% 6/449 • Number of events 9 • For serious adverse events (SAE): from randomization until the subject ends the study. For adverse events (AE) other than SAEs: during and within the 4 hours following each transfusion. Subjects ended the study 10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or at hospital discharge or death, whichever occurs first. Throughout their time on study, subjects were hospitalized. Assessment for AE and SAE was through review of medical records and daily assessment of subject.

Additional Information

Susan Assmann, PhD

New England Research Institutes

Phone: 617-923-7747

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place