Mobilization of Stem Cells With AMD3100 (Plerixafor) in N... | NCT00103610

Label	Type	Description	Intervention Names
G-CSF plus plerixafor	Experimental		Drug: Granulocyte colony-stimulating factor plus plerixafor
G-CSF plus placebo	Placebo Comparator		Drug: Granulocyte colony-stimulating factor plus placebo

Name	Type	Description	Arm Group Labels	Other Names
Granulocyte colony-stimulating factor plus plerixafor	Drug	Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of plerixafor (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of plerixafor followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.

Measure	Description	Time Frame
Proportion of Participants Able to Achieve Target (≥ 5*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis	Proportion of participants achieving a target of ≥ 5*10^6 CD34+ cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.	Days 5 to 8

Measure	Description	Time Frame
Number of Participants With Adverse Events	Number of participants with treatment emergent adverse events (AEs). The timeframe for treatment emergent AEs is defined as Day 1 (start of G-CSF Mobilization) to the day before starting chemotherapy (approximately 38 days later). AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale. AEs of Grade 3 were considered severe and Grade 4 were considered life-threatening.

Name	Affiliation	Role
Medical Monitor	Genzyme, a Sanofi Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope Samaritan Bone Marrow Transplant Program		Phoenix	Arizona	85006	United States
City of Hope National Medical Center

PubMed Identifier	Type	Citation	Retractions
19720922	Result	DiPersio JF, Micallef IN, Stiff PJ, Bolwell BJ, Maziarz RT, Jacobsen E, Nademanee A, McCarty J, Bridger G, Calandra G; 3101 Investigators. Phase III prospective randomized double-blind placebo-controlled trial of plerixafor plus granulocyte colony-stimulating factor compared with placebo plus granulocyte colony-stimulating factor for autologous stem-cell mobilization and transplantation for patients with non-Hodgkin's lymphoma. J Clin Oncol. 2009 Oct 1;27(28):4767-73. doi: 10.1200/JCO.2008.20.7209. Epub 2009 Aug 31.

Label	URL
Further information on non-Hodgkin's lymphoma from the National Cancer Institute	View source

ID	Title	Description
FG000	G-CSF Plus Plerixafor	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Proportion of Participants Able to Achieve Target (≥ 5*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis

Proportion of participants achieving a target of ≥ 5*10^6 CD34+ cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.

Intent-to-Treat Population

Posted

Number

proportion of participants

Days 5 to 8

ID	Title	Description
OG000	G-CSF Plus Plerixafor	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
OG001	G-CSF Plus Placebo	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.

Units	Counts
Participants	OG000150 OG001148

Title

Denominators

Categories

Proportion achieving target in ≤4 days

Title	Measurements
	OG0000.593 OG0010.196

Proportion not achieving target in ≤4 days

Title	Measurements
	OG000

Secondary

Number of Participants With Adverse Events

Number of participants with treatment emergent adverse events (AEs). The timeframe for treatment emergent AEs is defined as Day 1 (start of G-CSF Mobilization) to the day before starting chemotherapy (approximately 38 days later). AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale. AEs of Grade 3 were considered severe and Grade 4 were considered life-threatening.

Safety population of all participants who received at least 1 mobilization dose of G-CSF or study treatment (plerixafor or placebo). Three participants did not receive G-CSF or any study treatment and were excluded from the safety analyses.

Posted

Number

participants

up to Day 38

ID	Title	Description
OG000	G-CSF Plus Plerixafor	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
OG001	G-CSF Plus Placebo	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.

Secondary

Proportion of Participants Able to Achieve Target (>=2*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis

Proportion of participants achieving a target of >=2*10^6 CD34+ Cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.

Intent-to-treat Population

Posted

Number

proportion of participants

up to Day 8

ID	Title	Description
OG000	G-CSF Plus Plerixafor	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
OG001	G-CSF Plus Placebo	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.

Secondary

Median Number of Days of Apheresis Required to Achieve >=5*10^6 CD34+ Cells/kg

The Kaplan Meier estimate of median number of days (number of days at which 50% of participants reached the threshold, accounting for censored values) in each treatment arm to collect the target number of cells (≥5*10^6 CD34+ cells/kg) for transplantation. Central laboratory values were used.

Intent-to-Treat Population.

Posted

Median

Inter-Quartile Range

Days

up to Day 8

ID	Title	Description
OG000	G-CSF + Plerixafor	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
OG001	G-CSF Plus Placebo	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.

Units

Secondary

Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment

The Kaplan Meier estimate of median number of days to PMN engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. 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.

Participants who received a stem cell transplant.

Posted

Median

Inter-Quartile Range

Days

Up to Month 13

ID	Title	Description
OG000	G-CSF Plus Plerixafor	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
OG001	G-CSF Plus Placebo	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.

Secondary

Median Number of Days to Platelet (PLT) Engraftment

The Kaplan Meier estimate of median number of days to PLT engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as ≥ 20*10^9/L without transfusion for the preceding 7 days. Time to engraftment corresponded to the first day that the criteria were met.

Participants who received a stem cell transplant

Posted

Median

Inter-Quartile Range

Days

Up to Month 13

ID	Title	Description
OG000	G-CSF Plus Plerixafor	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
OG001	G-CSF Plus Placebo	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.

Secondary

Graft Durability at 100 Days Post Transplantation

The proportion of participants maintaining a durable graft at 100 days post transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.

Participants who received a stem cell transplant and were evaluable at 100 days post-transplant

Posted

Number

proportion of participants

approximately Day 138

ID	Title	Description
OG000	G-CSF Plus Plerixafor	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
OG001	G-CSF Plus Placebo	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.

Secondary

Graft Durability at 6 Months Post Transplantation

The proportion of participants maintaining a durable graft at 6 months post transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.

Participants who received a stem cell transplant and were evaluable at 6 months post-transplant

Posted

Number

proportion of participants

approximately Month 7

ID	Title	Description
OG000	G-CSF Plus Plerixafor	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
OG001	G-CSF Plus Placebo	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.

Secondary

Graft Durability at 12 Months Post Transplantation

The proportion of participants maintaining a durable graft 12 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.

Participants who received a stem cell transplant and were evaluable at 12 months post-transplant

Posted

Number

proportion of participants

approximately Month 13

ID	Title	Description
OG000	G-CSF Plus Plerixafor	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
OG001	G-CSF Plus Placebo	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected150 at risk EG0015 affected145 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0012 affected145 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected150 at risk EG0015 affected145 at risk
Angina pectoris	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Arrhythmia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0011 affected145 at risk
Extrasystoles	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0010 affected145 at risk
Palpitations	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0013 affected145 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Tachycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected150 at risk EG0014 affected145 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Ventricular tachyarrhythmia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0013 affected145 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected150 at risk EG0010 affected145 at risk
Hypothyroidism	Endocrine disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Eye swelling	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Vision blurred	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0011 affected145 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0011 affected145 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0009 affected150 at risk EG0013 affected145 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00010 affected150 at risk EG0014 affected145 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected150 at risk EG0010 affected145 at risk
Constipation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0013 affected145 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00065 affected150 at risk EG00120 affected145 at risk
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected150 at risk EG0014 affected145 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected150 at risk EG0010 affected145 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Eructation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Flatulence	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00011 affected150 at risk EG0017 affected145 at risk
Frequent bowel movements	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected150 at risk EG0016 affected145 at risk
Glossodynia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected150 at risk EG0010 affected145 at risk
Inflammatory bowel disease	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Nausea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00050 affected150 at risk EG00124 affected145 at risk
Oral mucosal blistering	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Oral mucosal petechiae	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Paraesthesia oral	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00011 affected150 at risk EG00113 affected145 at risk
Periodontitis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0011 affected145 at risk
Retching	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0010 affected145 at risk
Salivary hypersecretion	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Stomach discomfort	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected150 at risk EG0010 affected145 at risk
Tooth disorder	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Vomiting	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00012 affected150 at risk EG0018 affected145 at risk
Asthenia	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0012 affected145 at risk
Catheter related complication	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Catheter site discharge	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0013 affected145 at risk
Catheter site erythema	General disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected150 at risk EG0018 affected145 at risk
Catheter site haematoma	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0011 affected145 at risk
Catheter site haemorrhage	General disorders	MedDRA 10.0	Systematic Assessment	EG0006 affected150 at risk EG0017 affected145 at risk
Catheter site oedema	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0013 affected145 at risk
Catheter site pain	General disorders	MedDRA 10.0	Systematic Assessment	EG00018 affected150 at risk EG00121 affected145 at risk
Catheter site pruritus	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0013 affected145 at risk
Catheter site rash	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0012 affected145 at risk
Catheter site related reaction	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0014 affected145 at risk
Chest discomfort	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0012 affected145 at risk
Chest pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0012 affected145 at risk
Chills	General disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected150 at risk EG0016 affected145 at risk
Fatigue	General disorders	MedDRA 10.0	Systematic Assessment	EG00040 affected150 at risk EG00133 affected145 at risk
Feeling abnormal	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Feeling cold	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0010 affected145 at risk
Feeling hot	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0012 affected145 at risk
Immediate post-injection reaction	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Influenza like illness	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0012 affected145 at risk
Injection site bruising	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0013 affected145 at risk
Injection site discomfort	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Injection site erythema	General disorders	MedDRA 10.0	Systematic Assessment	EG00048 affected150 at risk EG00110 affected145 at risk
Injection site haematoma	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Injection site haemorrhage	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0013 affected145 at risk
Injection site irritation	General disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected150 at risk EG0010 affected145 at risk
Injection site pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected150 at risk EG0014 affected145 at risk
Injection site pruritus	General disorders	MedDRA 10.0	Systematic Assessment	EG00012 affected150 at risk EG0011 affected145 at risk
Injection site rash	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0011 affected145 at risk
Injection site reaction	General disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected150 at risk EG0012 affected145 at risk
Injection site swelling	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0010 affected145 at risk
Injection site urticaria	General disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected150 at risk EG0010 affected145 at risk
Local swelling	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Localised oedema	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Malaise	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Mucosal inflammation	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Non-cardiac chest pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0013 affected145 at risk
Oedema	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Oedema peripheral	General disorders	MedDRA 10.0	Systematic Assessment	EG00016 affected150 at risk EG00118 affected145 at risk
Pain	General disorders	MedDRA 10.0	Systematic Assessment	EG00012 affected150 at risk EG00115 affected145 at risk
Peripheral coldness	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0010 affected145 at risk
Pyrexia	General disorders	MedDRA 10.0	Systematic Assessment	EG0009 affected150 at risk EG0018 affected145 at risk
Sensation of pressure	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Submandibular mass	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Bacteraemia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Body tinea	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Bronchitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Candidiasis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Catheter bacteraemia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Cellulitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Central line infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0003 affected150 at risk EG0011 affected145 at risk
Erythema induratum	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0011 affected145 at risk
Folliculitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Herpes zoster	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Nasopharyngitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0013 affected145 at risk
Oral candidiasis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0011 affected145 at risk
Oral herpes	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Periodontal infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Rectal abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Rhinitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Sinusitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0010 affected145 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0003 affected150 at risk EG0013 affected145 at risk
Urinary tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Citrate toxicity	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 affected150 at risk EG0012 affected145 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0005 affected150 at risk EG0014 affected145 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0012 affected145 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0013 affected145 at risk
Blood creatinine increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Blood magnesium decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Blood potassium decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Blood pressure decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Blood pressure increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Blood uric acid increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0018 affected145 at risk
Body temperature increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0012 affected145 at risk
Breath sounds abnormal	Investigations	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0010 affected145 at risk
Electrocardiogram T wave inversion	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Hepatic enzyme increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Platelet count decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0013 affected145 at risk
Urine analysis abnormal	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Weight increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0011 affected145 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0013 affected145 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0011 affected145 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0011 affected145 at risk
Gout	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0010 affected145 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected150 at risk EG0014 affected145 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected150 at risk EG0013 affected145 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG00025 affected150 at risk EG00120 affected145 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG00017 affected150 at risk EG00112 affected145 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0010 affected145 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00023 affected150 at risk EG00119 affected145 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00031 affected150 at risk EG00130 affected145 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00040 affected150 at risk EG00141 affected145 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected150 at risk EG0016 affected145 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0011 affected145 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0015 affected145 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0010 affected145 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected150 at risk EG0014 affected145 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0010 affected145 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected150 at risk EG0017 affected145 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected150 at risk EG0015 affected145 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected150 at risk EG00110 affected145 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Amnesia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Areflexia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Balance disorder	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Convulsion	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Dizziness	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00013 affected150 at risk EG0018 affected145 at risk
Dizziness postural	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Dysgeusia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0011 affected145 at risk
Headache	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00037 affected150 at risk EG00127 affected145 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected150 at risk EG0016 affected145 at risk
Hypogeusia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Nystagmus	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Paraesthesia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00027 affected150 at risk EG00130 affected145 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Poor quality sleep	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Sedation	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Sensory disturbance	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Syncope	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0010 affected145 at risk
Syncope vasovagal	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Tremor	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0016 affected145 at risk
Abnormal dreams	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Anxiety	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected150 at risk EG0017 affected145 at risk
Confusional state	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Depression	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0010 affected145 at risk
Hallucination	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Insomnia	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG00011 affected150 at risk EG0014 affected145 at risk
Nightmare	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Restlessness	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Sleep disorder	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Dysuria	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected150 at risk EG0012 affected145 at risk
Haematuria	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0011 affected145 at risk
Urine odour abnormal	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Breast swelling	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Testicular pain	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected150 at risk EG0014 affected145 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0006 affected150 at risk EG0015 affected145 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0011 affected145 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0012 affected145 at risk
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Paranasal sinus hypersecretion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0010 affected145 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected150 at risk EG0012 affected145 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected150 at risk EG0012 affected145 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0012 affected145 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected150 at risk EG0012 affected145 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0008 affected150 at risk EG0013 affected145 at risk
Hypoaesthesia facial	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0011 affected145 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG00010 affected150 at risk EG0014 affected145 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0013 affected145 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0006 affected150 at risk EG0018 affected145 at risk
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected150 at risk EG0011 affected145 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Urticaria localised	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Flushing	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0008 affected150 at risk EG0015 affected145 at risk
Haematoma	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0010 affected145 at risk
Hot flush	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected150 at risk EG0012 affected145 at risk
Hypertension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0013 affected145 at risk
Hypotension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0008 affected150 at risk EG0012 affected145 at risk
Pallor	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected150 at risk EG0011 affected145 at risk

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates
D016298	Hematopoietic Cell Growth Factors
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011506	Proteins
D001685	Biological Factors

ID	Title	Description
BG000	G-CSF Plus Plerixafor	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
BG001	G-CSF Plus Placebo	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	G-CSF Plus Plerixafor	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.			8	150	145	150
EG001	G-CSF Plus Placebo	Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.			10	145	136	145

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected150 at risk EG0010 affected145 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected150 at risk EG0010 affected145 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected150 at risk EG0012 affected145 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected150 at risk EG0011 affected145 at risk
Non-cardiac chest pain	General disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected150 at risk EG0011 affected145 at risk
Pyrexia	General disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected150 at risk EG0010 affected145 at risk
Bacteraemia	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0000 affected150 at risk EG0011 affected145 at risk
Bacterial sepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0000 affected150 at risk EG0011 affected145 at risk
Catheter bacteraemia	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0001 affected150 at risk EG0010 affected145 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0000 affected150 at risk EG0011 affected145 at risk
Sinusitis	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0000 affected150 at risk EG0011 affected145 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected150 at risk EG0010 affected145 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment		EG0000 affected150 at risk EG0011 affected145 at risk
Metastases to skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	A coding error occurred in coding changes from MedDRA version 6.1 to 10.0. An infectious AE coded with the preferred term bacteraemia (MedDRA version 6.1) is now coded as metastases to skin (MedDRA version 10.0).	EG0001 affected150 at risk EG0010 affected145 at risk
Convulsion	Nervous system disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected150 at risk EG0010 affected145 at risk
Dizziness	Nervous system disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected150 at risk EG0010 affected145 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected150 at risk EG0011 affected145 at risk
Hypotension	Vascular disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected150 at risk EG0010 affected145 at risk

ID	Term
D016179	Granulocyte Colony-Stimulating Factor
C088327	plerixafor