Trial Outcomes & Findings for AMD3100 (Plerixafor) Added to a Mobilizing Regimen of Granulocyte-colony Stimulating Factor (G-CSF) to Increase the Number of Peripheral Blood Stem Cells (PBSCs) in Patients With Hodgkin's Disease (NCT NCT00396201)

NCT ID: NCT00396201

Last Updated: 2014-03-13

Results Overview

The proportion of total participants who mobilized ≥5\*10\^6 CD34+ cells/kg based on data from local laboratories.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

Day 5 up to Day 9

Results posted on

2014-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	Participants With Hodgkin's Disease (HD) Participants with Hodgkin's disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with granulocyte-colony stimulating factor (G-CSF) \[10 µg/kg each day (QD)\] and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5\*10\^6 cells/kg).
Treatment Period STARTED	22
Treatment Period COMPLETED	22
Treatment Period NOT COMPLETED	0
Follow-up Period STARTED	21
Follow-up Period COMPLETED	21
Follow-up Period NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

AMD3100 (Plerixafor) Added to a Mobilizing Regimen of Granulocyte-colony Stimulating Factor (G-CSF) to Increase the Number of Peripheral Blood Stem Cells (PBSCs) in Patients With Hodgkin's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants With Hodgkin's Disease (HD) n=22 Participants Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5\*10\^6 cells/kg).
Age, Continuous	34.0 years STANDARD_DEVIATION 12.5 • n=93 Participants
Sex: Female, Male Female	13 Participants n=93 Participants
Sex: Female, Male Male	9 Participants n=93 Participants
Race/Ethnicity, Customized Caucasian	22 participants n=93 Participants

PRIMARY outcome

Timeframe: Day 5 up to Day 9

Population: Intent to treat population which included all participants who received plerixafor.

The proportion of total participants who mobilized ≥5\*10\^6 CD34+ cells/kg based on data from local laboratories.

Outcome measures

Outcome measures
Measure	Participants With Hodgkin's Disease (HD) n=22 Participants Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5\*10\^6 cells/kg).
Proportion of Participants Who Achieved ≥510^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF Proportion achieving ≥510^6 CD34+ cells/kg	0.68 proportion of participants
Proportion of Participants Who Achieved ≥510^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF Proportion not achieving ≥510^6 CD34+ cells/kg	0.32 proportion of participants

SECONDARY outcome

Timeframe: Day 0 - approximately day 38

Population: Safety population consisting of all participants who received G-CSF and/or plerixafor.

Adverse Events were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe and life-threatening) and relatedness (5 steps from 'not related' to 'definitely related') to study treatment. Time frame starts on the first day of G-CSF mobilization to the day prior to chemotherapy/ablative treatment in preparation for transplant. See the separate Serious Adverse Event section for a summary of AEs the investigator assessed as serious.

Outcome measures

Outcome measures
Measure	Participants With Hodgkin's Disease (HD) n=22 Participants Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5\*10\^6 cells/kg).
Overall Participant Counts of Adverse Events During the Treatment Period Reporting at least one AE	17 participants
Overall Participant Counts of Adverse Events During the Treatment Period Severity - Mild	5 participants
Overall Participant Counts of Adverse Events During the Treatment Period Severity - Moderate	11 participants
Overall Participant Counts of Adverse Events During the Treatment Period Severity - Severe	1 participants
Overall Participant Counts of Adverse Events During the Treatment Period Severity - Life Threatening	0 participants
Overall Participant Counts of Adverse Events During the Treatment Period Relationship - Not Related	2 participants
Overall Participant Counts of Adverse Events During the Treatment Period Relationship - Probably Not Related	1 participants
Overall Participant Counts of Adverse Events During the Treatment Period Relationship - Possibly Related	12 participants
Overall Participant Counts of Adverse Events During the Treatment Period Relationship - Probably Related	1 participants
Overall Participant Counts of Adverse Events During the Treatment Period Relationship - Definitely Related	1 participants

SECONDARY outcome

Timeframe: Day 5 up to day 9

Population: Intent to treat population which included all participants who received plerixafor.

The proportion of total participants who mobilized ≥2\*10\^6 CD34+ cells/kg based on data from local laboratories.

Outcome measures

Outcome measures
Measure	Participants With Hodgkin's Disease (HD) n=22 Participants Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5\*10\^6 cells/kg).
Proportion of Participants Who Achieved ≥210^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF Proportion achieving ≥210^6 CD34+ cells/kg	0.95 proportion of participants
Proportion of Participants Who Achieved ≥210^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF Proportion not achieving ≥210^6 CD34+ cells/kg	0.05 proportion of participants

SECONDARY outcome

Timeframe: Days 4-5 (first dose of plerixafor to apheresis)

Population: Intent to treat population which included all participants who received plerixafor and had pre- and post-plerixafor CD34+ cell counts available; 3 participants had missing results data and were not included.

The fold increase was measured by fluorescence activated cell sorting (FACS) analysis using local laboratory data and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).

Outcome measures

Outcome measures
Measure	Participants With Hodgkin's Disease (HD) n=19 Participants Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5\*10\^6 cells/kg).
Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL	3.2 ratio Standard Deviation 1.1

SECONDARY outcome

Timeframe: Day 5 up to day 9

Population: Intent to treat population which included all participants who received plerixafor and achieved a target of ≥5\*10\^6 CD34+cells/kg

Counts of participants grouped by the number of apheresis days needed to collect a target for transplantation of ≥5\*10\^6 CD34+ cells/kg as determined by local laboratory data.

Outcome measures

Outcome measures
Measure	Participants With Hodgkin's Disease (HD) n=15 Participants Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5\*10\^6 cells/kg).
Participant Counts Grouped by Number of Apheresis Days Required to Collect ≥ 5*10^6 CD34+ Cells/kg 1 day of apheresis	7 participants 0.9 • Interval 1.0 to 3.0
Participant Counts Grouped by Number of Apheresis Days Required to Collect ≥ 5*10^6 CD34+ Cells/kg 2 days of apheresis	6 participants
Participant Counts Grouped by Number of Apheresis Days Required to Collect ≥ 5*10^6 CD34+ Cells/kg 3 days of apheresis	2 participants

SECONDARY outcome

Timeframe: Up to Month 13 (up to 12 months post transplant)

Population: Intent to treat population which included all participants who received plerixafor and had a transplant.

Median number of days to PMN engraftment following transplantation. Engraftment was defined as PMN counts ≥ 0.5\*10\^9/L for 3 consecutive days or ≥ 1.0\*10\^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met.

Outcome measures

Outcome measures
Measure	Participants With Hodgkin's Disease (HD) n=21 Participants Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5\*10\^6 cells/kg).
Number of Days Post-Transplantation to Polymorphonuclear Leukocyte (PMN) Engraftment	9.0 days Full Range 1.2 • Interval 8.0 to 14.0

SECONDARY outcome

Timeframe: Up to Month 13 (up to 12 months post transplant)

Population: Intent to treat population which included all participants who received plerixafor and had a transplant. One participant's time to engraftment was unknown due to missing lab values.

Median number of days to PLT engraftment following transplantation. Engraftment success was evaluated according to local site practice. Time to engraftment corresponded to the first day that criteria were met.

Outcome measures

Outcome measures
Measure	Participants With Hodgkin's Disease (HD) n=20 Participants Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5\*10\^6 cells/kg).
Number of Days Post Transplantation to Platelet (PLT) Engraftment	19.0 days Full Range 3.8 • Interval 11.0 to 29.0

SECONDARY outcome

Timeframe: 13 months

Population: Intent to treat population which included all participants who received plerixafor and had a transplant.

Graft durability was assessed by the Investigator based on complete blood count (CBC) and differential analyses at 12 months post transplantation. A graft was considered durable if blood counts were normal (acceptable) and still met the criteria for PLT and PMN engraftment.

Outcome measures

Outcome measures
Measure	Participants With Hodgkin's Disease (HD) n=21 Participants Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5\*10\^6 cells/kg).
Number of Participants With a Durable Graft at 12 Months	21 participants

SECONDARY outcome

Timeframe: Day 4

Population: The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.

Maximum plasma concentration (Cmax) of plerixafor following the first single dose of 240 ug/kg plerixafor administered.

Outcome measures

Outcome measures
Measure	Participants With Hodgkin's Disease (HD) n=9 Participants Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5\*10\^6 cells/kg).
Maximum Plasma Concentration (Cmax) Following a Single Dose of Plerixafor	831 ng/mL Standard Deviation 183

SECONDARY outcome

Timeframe: Day 4

Time to maximum plasma concentration (Tmax) of plerixafor following the first single dose of 240 ug/kg plerixafor was determined from direct observation of the data.

Outcome measures

Outcome measures
Measure	Participants With Hodgkin's Disease (HD) n=9 Participants Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5\*10\^6 cells/kg).
Time to Maximum Plasma Concentration (Tmax) Following a Single Dose of Plerixafor	0.6 hours Standard Deviation 0.4

SECONDARY outcome

Timeframe: Day 4

Plasma elimination half-life (T1/2) following a single dose of 240 ug/kg plerixafor.

Outcome measures

Outcome measures
Measure	Participants With Hodgkin's Disease (HD) n=8 Participants Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5\*10\^6 cells/kg).
Half-life (T1/2) Following a Single Dose of Plerixafor	3.5 hours Standard Deviation 0.7

SECONDARY outcome

Timeframe: Days 4-5

Area under the plasma concentration-time curve from 0 to 10 hours (AUC0-10) following the first single dose of 240 ug/kg plerixafor.

Outcome measures

Outcome measures
Measure	Participants With Hodgkin's Disease (HD) n=9 Participants Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5\*10\^6 cells/kg).
Area Under the Plasma Concentration-time Curve From 0 to 10 Hours (AUC0-10) Following a Single Dose of Plerixafor	3572 ng*hr/mL Standard Deviation 772

SECONDARY outcome

Timeframe: Day 4-5

Apparent clearance was calculated the mean dose of plerixafor divided by the area under the plasma concentration-time curve from 0 hours to infinity (AUC0-inf).

Outcome measures

Outcome measures
Measure	Participants With Hodgkin's Disease (HD) n=8 Participants Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5\*10\^6 cells/kg).
Apparent Clearance (CL/F) of Single-dose Plerixafor	5138 mL/hr Standard Deviation 2029

SECONDARY outcome

Timeframe: Day 4

The volume of distribution (Vz/F) was calculated as apparent clearance divided by the terminal elimination rate constant.

Outcome measures

Outcome measures
Measure	Participants With Hodgkin's Disease (HD) n=8 Participants Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5\*10\^6 cells/kg).
Apparent Volume of Distribution (Vz/F) Following a Single-dose of Plerixafor	25464 mL Standard Deviation 9002

Adverse Events

Participants With Hodgkin's Disease (HD)

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Participants With Hodgkin's Disease (HD) n=22 participants at risk Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5\*10\^6 cells/kg).
Gastrointestinal disorders Abdominal discomfort	4.5% 1/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Gastrointestinal disorders Abdominal pain	4.5% 1/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Gastrointestinal disorders Diarrhoea	13.6% 3/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Gastrointestinal disorders Hypoaesthesia oral	9.1% 2/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Gastrointestinal disorders Nausea	27.3% 6/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Gastrointestinal disorders Paraesthesia oral	18.2% 4/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Gastrointestinal disorders Vomiting	9.1% 2/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
General disorders Catheter site haematoma	4.5% 1/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
General disorders Catheter site haemorrhage	4.5% 1/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
General disorders Catheter site pain	4.5% 1/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
General disorders Chills	9.1% 2/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
General disorders Face oedema	4.5% 1/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
General disorders Fatigue	22.7% 5/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
General disorders Feeling hot	4.5% 1/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
General disorders Injection site discharge	4.5% 1/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
General disorders Injection site erythema	68.2% 15/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
General disorders Injection site haemorrhage	13.6% 3/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
General disorders Injection site irritation	4.5% 1/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
General disorders Injection site swelling	4.5% 1/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
General disorders Oedema peripheral	4.5% 1/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
General disorders Pain	9.1% 2/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
General disorders Pyrexia	4.5% 1/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Metabolism and nutrition disorders Hypocalcaemia	9.1% 2/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Musculoskeletal and connective tissue disorders Arthralgia	13.6% 3/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Musculoskeletal and connective tissue disorders Back pain	31.8% 7/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Musculoskeletal and connective tissue disorders Bone pain	27.3% 6/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Musculoskeletal and connective tissue disorders Muscle spasms	4.5% 1/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	13.6% 3/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	9.1% 2/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Musculoskeletal and connective tissue disorders Neck pain	4.5% 1/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Musculoskeletal and connective tissue disorders Pain in extremity	4.5% 1/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Nervous system disorders Dizziness	4.5% 1/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Nervous system disorders Headache	9.1% 2/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Nervous system disorders Hypoaesthesia	9.1% 2/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Nervous system disorders Neuropathy peripheral	4.5% 1/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Nervous system disorders Paraesthesia	22.7% 5/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Psychiatric disorders Nervousness	4.5% 1/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.5% 1/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	4.5% 1/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Skin and subcutaneous tissue disorders Hyperhidrosis	4.5% 1/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Skin and subcutaneous tissue disorders Hypoaesthesia facial	9.1% 2/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Skin and subcutaneous tissue disorders Night sweats	4.5% 1/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Vascular disorders Pallor	9.1% 2/22 • Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8). In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.

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