Trial Outcomes & Findings for Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for White Blood Cell Depletion (NCT NCT02302365)

Results Overview

Percent decrease in WBC count calculation: (WBCpre - WBCpost) / WBCpre x 100%

Recruitment status

COMPLETED

Target enrollment

43 participants

Primary outcome timeframe

immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure

Results posted on

2018-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	Subjects Who Received a Minimum of 1 WBCD Procedure Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
0-2 Hour Period STARTED	43
0-2 Hour Period COMPLETED	41
0-2 Hour Period NOT COMPLETED	2
0-24 Hour Period STARTED	32
0-24 Hour Period COMPLETED	32
0-24 Hour Period NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects Who Received At Least 1 WBCD Apheresis Procedure n=43 Participants Eligible subjects who received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
Age, Continuous	51.9 years STANDARD_DEVIATION 17.1 • n=43 Participants
Sex: Female, Male Female	16 Participants n=43 Participants
Sex: Female, Male Male	27 Participants n=43 Participants
Region of Enrollment Belgium	9 participants n=43 Participants
Region of Enrollment Germany	11 participants n=43 Participants
Region of Enrollment Hungary	23 participants n=43 Participants
Weight	73.2 kg STANDARD_DEVIATION 16.7 • n=43 Participants
Height	170.9 cm STANDARD_DEVIATION 10.3 • n=43 Participants
Total Blood Volume	4.7 Liters STANDARD_DEVIATION 0.8 • n=43 Participants

PRIMARY outcome

Timeframe: immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure

Population: The Full Analysis Set comprised all 43 patients (58 procedures) for whom WBCD data were collected. One patient terminated the first procedure prematurely and therefore did not have post-procedure data, resulting in a total of 57 units analyzed.

Percent decrease in WBC count calculation: (WBCpre - WBCpost) / WBCpre x 100%

Outcome measures

Outcome measures
Measure	WBCD Procedures Performed n=57 procedures Eligible subjects received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System; 58 WBCD procedures were performed in 43 patients	Safety Data Collection 0-24 Hours Post Apheresis Procedure 41 WBCD procedures were performed in 32 patients. Safety data was collected for up to 24 hours post apheresis procedure
Percent Decrease in White Blood Cell Count in Patient Following Apheresis Procedure	54.5 % change in subject's WBC count Standard Deviation 21.40	—

PRIMARY outcome

Timeframe: immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure

Population: The CE of the WBCD procedures was measured from the waste bag (depletion product) contents from Sites 2 and 3. WBC counts were not available from the waste bags for subjects treated at Site 1.

Collection efficiency for WBC achieved by Spectra Optia System calculation: (WBC/µL depletion product x depletion product volume) / (WBCpre + WBCpost) / 2 x total processed blood volume)

Outcome measures

Outcome measures
Measure	WBCD Procedures Performed n=43 procedures Eligible subjects received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System; 58 WBCD procedures were performed in 43 patients	Safety Data Collection 0-24 Hours Post Apheresis Procedure 41 WBCD procedures were performed in 32 patients. Safety data was collected for up to 24 hours post apheresis procedure
Collection Efficiency (CE) for WBC (or Percent of Processed WBCs) Achieved by Spectra Optia.	58.7 percent of processed WBCs Standard Deviation 16.1	—

PRIMARY outcome

Timeframe: Participants were followed for the duration of the procedure and for up to 24 hours after the procedure.

Population: Full and Safety Analysis Sets. 53.5% of subjects with acute myeloid leukemia (AML), 18.6% of subjects with chronic lymphocytic leukemia, \< 10% of subjects with other diagnoses. The WBCD procedure was performed most frequently to treat leukocytosis (44.2%), to prevent tumor lysis syndrome (34.9%), or to treat increased blood viscosity (20.9%).

Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medical device, whether or not considered related to the medical device and/or procedure. Therefore, an AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the medical device and/or procedure.

Outcome measures

Outcome measures
Measure	WBCD Procedures Performed n=43 Participants Eligible subjects received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System; 58 WBCD procedures were performed in 43 patients	Safety Data Collection 0-24 Hours Post Apheresis Procedure n=32 Participants 41 WBCD procedures were performed in 32 patients. Safety data was collected for up to 24 hours post apheresis procedure
Adverse Events	37 Number of subjects with at least 1 TEAE	30 Number of subjects with at least 1 TEAE

OTHER_PRE_SPECIFIED outcome

Timeframe: Prior to Each Spectra Optia Apheresis Procedure

Population: The Full Analysis Set comprised all 43 patients (58 procedures) for whom WBCD data were collected.

Pre-procedure WBC count

Outcome measures

Outcome measures
Measure	WBCD Procedures Performed n=58 procedures Eligible subjects received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System; 58 WBCD procedures were performed in 43 patients	Safety Data Collection 0-24 Hours Post Apheresis Procedure 41 WBCD procedures were performed in 32 patients. Safety data was collected for up to 24 hours post apheresis procedure
Pre-procedure WBC Count	243.5 cells x 10^9/L Standard Deviation 175.6	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Following apheresis procedure

Population: Data were collected on a total of 58 procedures, however one patient terminated the first procedure prematurely and therefore did not have post-procedure data.

Post-procedure WBC count

Outcome measures

Outcome measures
Measure	WBCD Procedures Performed n=57 procedure Eligible subjects received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System; 58 WBCD procedures were performed in 43 patients	Safety Data Collection 0-24 Hours Post Apheresis Procedure 41 WBCD procedures were performed in 32 patients. Safety data was collected for up to 24 hours post apheresis procedure
Post-procedure WBC Count	119.9 cells x 10^9/L Standard Deviation 156.05	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Prior to Each Spectra Optia Apheresis Procedure

Population: Full and Safety Analysis Sets.

Patient's platelet count pre-depletion procedure

Outcome measures

Outcome measures
Measure	WBCD Procedures Performed n=58 procedures Eligible subjects received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System; 58 WBCD procedures were performed in 43 patients	Safety Data Collection 0-24 Hours Post Apheresis Procedure 41 WBCD procedures were performed in 32 patients. Safety data was collected for up to 24 hours post apheresis procedure
Patient's Platelet Count Pre-depletion Procedure	88.1 cells x 10^3/L Standard Deviation 75.58	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.

Population: Full and Safety Analysis Sets. Data were collected on a total of 58 procedures, however one patient terminated her first procedure prematurely and therefore did not have post-procedure data.

Patient's platelet count post-depletion procedure

Outcome measures

Outcome measures
Measure	WBCD Procedures Performed n=57 procedures Eligible subjects received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System; 58 WBCD procedures were performed in 43 patients	Safety Data Collection 0-24 Hours Post Apheresis Procedure 41 WBCD procedures were performed in 32 patients. Safety data was collected for up to 24 hours post apheresis procedure
Patient's Platelet Count Post-depletion Procedure	59.5 cells x 10^3/L Standard Deviation 53.50	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.

Population: Full and Safety Analysis Sets

Volume of patient's blood processed in mL during the apheresis procedure

Outcome measures

Outcome measures
Measure	WBCD Procedures Performed n=58 procedures Eligible subjects received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System; 58 WBCD procedures were performed in 43 patients	Safety Data Collection 0-24 Hours Post Apheresis Procedure 41 WBCD procedures were performed in 32 patients. Safety data was collected for up to 24 hours post apheresis procedure
Whole Blood Processed (mL)	11395 mL Standard Deviation 4010	—

POST_HOC outcome

Timeframe: Post each Spectra Optia Apheresis Procedure

Population: Full and Safety Analysis Sets

Number of times the patient's TBV was processed during the apheresis procedure based on the patient's estimated TBV (Estimated by Nadler's formula for total blood volume of a human being based on gender, height, and weight).

Outcome measures

Outcome measures
Measure	WBCD Procedures Performed n=58 procedures Eligible subjects received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System; 58 WBCD procedures were performed in 43 patients	Safety Data Collection 0-24 Hours Post Apheresis Procedure 41 WBCD procedures were performed in 32 patients. Safety data was collected for up to 24 hours post apheresis procedure
Total Blood Volumes (TBV) Processed	2.5 TBV Standard Deviation 0.9	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.

Population: Full and Safety Analysis Set

Whole Blood Flow in mL/min measured during the white blood cell depletion procedure

Outcome measures

Outcome measures
Measure	WBCD Procedures Performed n=58 procedures Eligible subjects received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System; 58 WBCD procedures were performed in 43 patients	Safety Data Collection 0-24 Hours Post Apheresis Procedure 41 WBCD procedures were performed in 32 patients. Safety data was collected for up to 24 hours post apheresis procedure
Whole Blood Flow mL/Min	50.3 mL/min Standard Deviation 12.8	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.

Population: Full and Safety Analysis Sets

The duration of the WBCD procedure measured in minutes

Outcome measures

Outcome measures
Measure	WBCD Procedures Performed n=58 procedures Eligible subjects received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System; 58 WBCD procedures were performed in 43 patients	Safety Data Collection 0-24 Hours Post Apheresis Procedure 41 WBCD procedures were performed in 32 patients. Safety data was collected for up to 24 hours post apheresis procedure
Procedure Duration	237.3 minutes Standard Deviation 97.38	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.

Population: Data were collected on a total of 58 procedures, however one patient terminated her first procedure prematurely and therefore did not have post-procedure data.

% change in patient's pre and post-depletion procedure platelet counts

Outcome measures

Outcome measures
Measure	WBCD Procedures Performed n=57 procedures Eligible subjects received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System; 58 WBCD procedures were performed in 43 patients	Safety Data Collection 0-24 Hours Post Apheresis Procedure 41 WBCD procedures were performed in 32 patients. Safety data was collected for up to 24 hours post apheresis procedure
Platelet Change (% Change)	20.8 percent change Standard Deviation 62.15	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Post each Spectra Optia Apheresis Procedure

Population: Full and Safety Analysis Sets; One patient terminated the first procedure prematurely, resulting in a total of 57 units analyzed.

Volume of the depletion product

Outcome measures

Outcome measures
Measure	WBCD Procedures Performed n=57 procedures Eligible subjects received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System; 58 WBCD procedures were performed in 43 patients	Safety Data Collection 0-24 Hours Post Apheresis Procedure 41 WBCD procedures were performed in 32 patients. Safety data was collected for up to 24 hours post apheresis procedure
Waste Bag Volume	1371.2 mL Standard Deviation 896.20	—

Adverse Events

0-2 Hour Safety Data Collection

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

0-24 Hour Safety Data Collection

Serious events: 1 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	0-2 Hour Safety Data Collection n=43 participants at risk Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System; safety data collected for 2 hours post apheresis procedure	0-24 Hour Safety Data Collection n=32 participants at risk Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System; safety data collected for 24 hours post apheresis procedure
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/43 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).	3.1% 1/32 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).

Other adverse events

Other adverse events
Measure	0-2 Hour Safety Data Collection n=43 participants at risk Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System; safety data collected for 2 hours post apheresis procedure	0-24 Hour Safety Data Collection n=32 participants at risk Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System; safety data collected for 24 hours post apheresis procedure
Blood and lymphatic system disorders Thrombocytopenia	53.5% 23/43 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).	59.4% 19/32 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).
Blood and lymphatic system disorders Anaemia	34.9% 15/43 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).	40.6% 13/32 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).
Metabolism and nutrition disorders Hypocalcaemia	34.9% 15/43 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).	43.8% 14/32 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).
Investigations Platelet count decreased	27.9% 12/43 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).	15.6% 5/32 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).
Metabolism and nutrition disorders Hypokalaemia	25.6% 11/43 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).	34.4% 11/32 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).
Metabolism and nutrition disorders Hypoalbuminaemia	30.2% 13/43 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).	43.8% 14/32 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).
Blood and lymphatic system disorders Coagulopathy	4.7% 2/43 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).	9.4% 3/32 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).
General disorders Fatigue	2.3% 1/43 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).	9.4% 3/32 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).
Injury, poisoning and procedural complications Procedural hypotension	7.0% 3/43 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).	9.4% 3/32 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).
Metabolism and nutrition disorders Hypomagnesaemia	4.7% 2/43 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).	9.4% 3/32 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).
Gastrointestinal disorders Nausea	0.00% 0/43 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).	6.2% 2/32 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).
Immune system disorders Hypogammaglobulinaemia	2.3% 1/43 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).	6.2% 2/32 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).
Psychiatric disorders Anxiety	0.00% 0/43 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).	6.2% 2/32 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).
Vascular disorders Hypotension	2.3% 1/43 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).	6.2% 2/32 • Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).

Additional Information

Isobelle Galeon, MD, MPH, MSCS, Medical Monitor Clinical Safety

Terumo BCT

Phone: +1 303 542-5166

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Study Site reserves the right to publish the results of its work on the Study. The timing of publication however shall not exceed the 6 months after completion of the Study. Study Site and the PI agree to submit copies of any manuscript/abstract proposed for publication to Sponsor at least 30 days in advance of the presentation. Sponsor may require the delay of publication for no longer than 90 days for the purpose of filing patent applications.
Publication restrictions are in place

Restriction type: OTHER