Trial to Evaluate Palifermin in the Reduction of Acute Gr... | NCT00189488

Name	Class
Amgen	INDUSTRY

Label	Type	Description	Intervention Names
Palifermin	Experimental	Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg. Participants received conditioning therapy starting at least 24 hours after the last 60 μg dose of palifermin. Allogeneic stem cell transplant occurred on Day 0. Methotrexate dosing began at least 24 hours after the 180 μg/kg dose of palifermin on Days 1, 3, 6 and (planned) 11 administration (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m^2 respectively.	Drug: Palifermin Other: Conditioning Regimen Procedure: Allogeneic stem cell transplant Drug: Methotrexate
Placebo	Placebo Comparator	Placebo to palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to palifermin 180 μg/kg once prior to transplant and at least 96 hours from previous placebo to palifermin 60 μg/kg dose. Participants received conditioning therapy starting at least 24 hours after the last 60 μg/kg dose of placebo to palifermin. Allogeneic stem cell transplant occurred on Day 0. Methotrexate dosing began at least 24 hours after the dose of placebo to palifermin 180 μg/kg on Days 1, 3, 6 and (planned) 11 administration (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m^2 respectively.	Drug: Placebo Other: Conditioning Regimen Procedure: Allogeneic stem cell transplant Drug: Methotrexate

Name	Type	Description	Arm Group Labels	Other Names
Palifermin	Drug	Administered as an intravenous (IV) bolus.	Palifermin

Measure	Description	Time Frame
Number of Participants With Severe (Grade 3 and 4) Acute Graft Versus Host Disease (GVHD)	GVHD was graded using the modified Keystone Criteria weekly during the first 2 months after stem cell infusion, then every other week until Day 100. Severity was determined clinically (based on physical exam and laboratory serum values) and from biopsies of affected organs whenever possible. The degree of GVHD in individual organs was scored by at least 2 assessors. Grade 3 GVHD = total bilirubin 3.1 - 15.0 mg/dL or ≥ 1000 mL/day diarrhea or severe abdominal pain with/without ileus. Grade 4 GVHD = skin involvement with bullous formation or total bilirubin > 15.0 mg/dL.	From transplant (Day 0) until Day 100

Measure	Description	Time Frame
Number of Participants With Grade 2 to 4 Acute Graft Versus Host Disease (GVHD)	GVHD was graded using the modified Keystone Criteria weekly during the first 2 months after stem cell infusion, then every other week until Day 100. Severity was determined clinically (based on physical exam and laboratory serum values) and from biopsies of affected organs whenever possible. The degree of GVHD in individual organs was scored by at least 2 assessors. Grade 2 GVHD = > 50% skin involvement or total bilirubin 2.0 - 3.0 mg/dL or 500 - 999 mL/day diarrhea, or persistent nausea with histologic evidence. Grade 3 GVHD = total bilirubin 3.1 - 15.0 mg/dL or ≥ 1000 mL/day diarrhea or severe abdominal pain with/without ileus. Grade 4 GVHD = skin involvement with bullous formation or total bilirubin > 15.0 mg/dL.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with hematologic malignancies (including myelodysplastic syndromes [MDS]) who are considered eligible for Cyclophosphamide (Cy)/Total Body Irradiation(TBI) +/- Etoposide (VP-16); Total Body Irradiation(TBI)/ Etoposide(VP-16); Melphalan(Mel) / Total Body Irradiation(TBI); Busulfan(Bu)/ Cyclophosphamide(Cy); Busulfan(Bu)/ Melphalan (Mel); or Fludarabine(Flu)/ Melphalan(Mel) conditioning therapy with allogeneic stem cell support
Subjects with a 6/6 Human Leukocyte Antigen (HLA)-matched family member or unrelated donor who would provide donor marrow/ peripheral progenitor stem cells. [For unrelated matched donors, molecular typing of class I and class II is mandatory]
Karnofsky Performance Status >= 70%
18 years of age or older at time of informed consent
Before any study-specific procedure, the appropriate written informed consent must be obtained

Exclusion Criteria:

Cancer other than Non-Hodgkin's lymphoma, Hodgkin's disease, acute myelogenous leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, chronic lymphocytic leukemia, myelodysplastic syndrome or multiple myeloma (except: adequately treated basal cell carcinoma of the skin)
Prior autologous or allogeneic bone marrow or peripheral blood stem cell transplantation
Previous use of palifermin
Current active infection (including human immunodeficiency virus (HIV) and hepatitis) or oral mucositis
Congestive heart failure as defined by New York Heart Association class III or IV
Graft T-cell depletion for Graft-versus-host disease (GVHD) prophylaxis
Inadequate renal function (serum creatinine > 1.5x the upper limit of normal per the institutional guidelines or clearance < 40 ml/min adjusted for age)
Inadequate liver function (total bilirubin > 1.5x the upper limit of normal, aspartate aminotransferase (AST) > 3x upper limit of normal and/or alanine aminotransferase (ALT) > 3x upper limit of normal per the institutional guidelines)
Inadequate pulmonary function as measured by a corrected DLCO (diffusing capacity of the lung for carbon monoxide lung function test) <50% of predicted
Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s)
Subject of child-bearing potential is evidently pregnant (e.g. positive human chorionic gonadotropin- HCG test) or is breast feeding during Part A of the study
Subject or partner of subject is not using or refuses to use adequate contraceptive precautions during Part A of the study
Subject has known sensitivity to any of the products to be administered during dosing including Escherichia coli-derived products
Subject was previously randomized into this study
Subject will not be available for follow-up assessments
Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures

Name	Affiliation	Role
MD	Amgen	Study Director

ID	Title	Description
FG000	Placebo	Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin once prior to transplant and at least 96 hours from the previous placebo dose. Participants received conditioning therapy starting at least 24 hours after the last 60 μg/kg dose of placebo to palifermin. Allogeneic stem cell transplant occurred on Day 0. Methotrexate dosing began at least 24 hours after the dose of placebo to palifermin 180 μg/kg on Days 1, 3, 6 and (planned) 11 administration (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m^2 respectively.

ID	Title	Description
BG000	Placebo	Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
BG001	Palifermin	Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00078 BG00177 BG002155

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

Secondary

Number of Participants With Grade 2 to 4 Acute Graft Versus Host Disease (GVHD)

GVHD was graded using the modified Keystone Criteria weekly during the first 2 months after stem cell infusion, then every other week until Day 100.

Severity was determined clinically (based on physical exam and laboratory serum values) and from biopsies of affected organs whenever possible. The degree of GVHD in individual organs was scored by at least 2 assessors.

Grade 2 GVHD = > 50% skin involvement or total bilirubin 2.0 - 3.0 mg/dL or 500 - 999 mL/day diarrhea, or persistent nausea with histologic evidence.

Grade 3 GVHD = total bilirubin 3.1 - 15.0 mg/dL or ≥ 1000 mL/day diarrhea or severe abdominal pain with/without ileus.

Grade 4 GVHD = skin involvement with bullous formation or total bilirubin > 15.0 mg/dL.

Primary Analysis Set (consisting of all randomized participants) with GVHD assessments.

Posted

Number

Participants

From transplant (Day 0) until Day 100

ID	Title	Description
OG000	Placebo	Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
OG001	Palifermin	Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.

Units	Counts
Participants	OG00072 OG00174

Title

Denominators

Categories

Yes

Title	Measurements
	OG00029 OG00143

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel	Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.	0.034		Adjusted Treatment Difference (%)	-17.9			2-Sided	95	-33.4	-2.4			The difference between treatment groups in the percentage of participants with Grade 2 to 4 acute GVHD, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.	No	Superiority or Other

Primary

Number of Participants With Severe (Grade 3 and 4) Acute Graft Versus Host Disease (GVHD)

GVHD was graded using the modified Keystone Criteria weekly during the first 2 months after stem cell infusion, then every other week until Day 100.

Grade 3 GVHD = total bilirubin 3.1 - 15.0 mg/dL or ≥ 1000 mL/day diarrhea or severe abdominal pain with/without ileus.

Grade 4 GVHD = skin involvement with bullous formation or total bilirubin > 15.0 mg/dL.

Primary Analysis Set (consisting of all randomized participants) with GVHD assessments. Efficacy analyses were according to randomized treatment assignment.

Posted

Number

Participants

From transplant (Day 0) until Day 100

ID	Title	Description
OG000	Placebo	Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
OG001	Palifermin	Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.

Secondary

Number of Participants With Day 11 Methotrexate Graft Versus Host Disease Prophylaxis Administration

Low dose methotrexate is widely used in regimens to prophylax against acute GVHD. Methotrexate was administered on days 1, 3, 6 and 11 (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m^2, respectively.

Primary Analysis Set

Posted

Number

Participants

Day 11

ID	Title	Description
OG000	Placebo	Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
OG001	Palifermin	Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.

Units	Counts
Participants

Secondary

Number of Participants With Severe (Grade 3 or 4) Oral Mucositis

Oral cavity assessments were performed by a trained assessor using the World Health Organization (WHO) oral toxicity scale. Daily oral mucositis assessments were performed:

while participants were hospitalized, including the day of discharge (maximum until day 28);
after discharge until the oral mucositis grade returns to a WHO grade ≤ 2.

The WHO oral toxicity criteria are: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.

Primary Analysis Set

Posted

Number

Participants

From transplant (Day 0) until Day 100

ID	Title	Description
OG000	Placebo	Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
OG001	Palifermin	Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.

Secondary

Duration of Severe Oral Mucositis (WHO Grade 3 and 4)

The duration of severe oral mucositis was calculated as the number of days from the onset of severe mucositis (first time a WHO grade of 3 or 4 was observed) to the last day when severe mucositis was observed. If oral mucositis assessments were recorded as missed visits immediately prior to or immediately after severe mucositis was recorded, the missed visits were considered to be severe oral mucositis.

Primary Analysis Set

Posted

Mean

Standard Deviation

days

From transplant (Day 0) until Day 100

ID	Title	Description
OG000	Placebo	Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
OG001	Palifermin	Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.

Units	Counts
Participants

Secondary

Number of Participants With Parenteral or Transdermal Opioid Analgesic Use

Includes nonprophylactic intravenous opioid analgesics (fentanyl, morphine, morphine sulphate, hydromorphone, meperidine) and transdermal opioid analgesics (fentanyl patch) for the indication of oral mucositis and dysphagia.

Primary Analysis Set

Posted

Number

Participants

From transplant (Day 0) until Day 100

ID	Title	Description
OG000	Placebo	Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
OG001	Palifermin	Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.

Units	Counts
Participants

Secondary

Duration of Hospitalization

Duration of hospitalization was defined as the number of days a participant stayed in hospital (hospitalized) during the period starting from the day of the transplant (Day 0) to the 100th day following the transplant.

Primary analysis set

Posted

Mean

Standard Deviation

days

From transplant (Day 0) until Day 100

ID	Title	Description
OG000	Placebo	Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
OG001	Palifermin	PaPalifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.

Units	Counts
Participants	OG000

Secondary

Area Under the Curve (AUC) of Mouth and Throat Soreness Score

The modified Oral Mucositis Daily Questionnaire (OMDQ) is a self-reported tool that evaluates overall health, mouth and throat soreness (MTS) and activity limitations due to MTS.

The modified OMDQ was completed once daily beginning with the first day of study drug administration through day 28.

The area under the curve of mouth and throat soreness score was assessed from the question "How much mouth and throat soreness did you experience in the past 24 hours?" Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness).

Primary analysis set

Posted

Mean

Standard Deviation

MTS score * days

The first day of study drug administration through Day 28.

ID	Title	Description
OG000	Placebo	Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
OG001	Palifermin	Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0012 affected78 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0012 affected78 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Angina pectoris	Cardiac disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0012 affected78 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0011 affected78 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Tachycardia	Cardiac disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0011 affected78 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0003 affected73 at risk EG0011 affected78 at risk
Caecitis	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0003 affected73 at risk EG0012 affected78 at risk
Gastritis	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Nausea	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0014 affected78 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Oral pain	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Pneumatosis intestinalis	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Vomiting	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0003 affected73 at risk EG0012 affected78 at risk
Asthenia	General disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Face oedema	General disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Fatigue	General disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Mucosal inflammation	General disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0012 affected78 at risk
Multi-organ failure	General disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0013 affected78 at risk
Oedema peripheral	General disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Pyrexia	General disorders	MedDRA 9.0	Systematic Assessment	EG00010 affected73 at risk EG00110 affected78 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Graft versus host disease	Immune system disorders	MedDRA 9.0	Systematic Assessment	EG00012 affected73 at risk EG00117 affected78 at risk
Graft versus host disease in liver	Immune system disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Immunodeficiency	Immune system disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Transplant rejection	Immune system disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0011 affected78 at risk
Bacteraemia	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0005 affected73 at risk EG0012 affected78 at risk
Bacterial infection	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Catheter related infection	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0012 affected78 at risk
Catheter sepsis	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Cellulitis	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Central line infection	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0002 affected73 at risk EG0011 affected78 at risk
Enterobacter infection	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Enterococcal infection	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0002 affected73 at risk EG0010 affected78 at risk
Escherichia infection	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Febrile infection	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Herpes simplex	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Influenza	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Mycobacterial infection	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Pneumonia	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0003 affected73 at risk EG0012 affected78 at risk
Pneumonia aspergillus	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Pneumonia cytomegaloviral	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0011 affected78 at risk
Pseudomonas infection	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Rectal abscess	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Respiratory tract infection	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Sepsis	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0015 affected78 at risk
Septic shock	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0011 affected78 at risk
Sinusitis	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0002 affected73 at risk EG0010 affected78 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Staphylococcal infection	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0003 affected73 at risk EG0014 affected78 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Tooth abscess	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Medical device pain	Injury, poisoning and procedural complications	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Therapeutic agent toxicity	Injury, poisoning and procedural complications	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Atrial natriuretic peptide increased	Investigations	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Blood creatinine increased	Investigations	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Blood culture	Investigations	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Cytomegalovirus antigen positive	Investigations	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Cytomegalovirus test	Investigations	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0012 affected78 at risk
Weight decreased	Investigations	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0012 affected78 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0011 affected78 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Oral intake reduced	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0013 affected78 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0012 affected78 at risk
Tumour lysis syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Cerebral haematoma	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Convulsion	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected73 at risk EG0013 affected78 at risk
Dizziness	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Reversible posterior leukoencephalopathy syndrome	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Syncope	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0012 affected78 at risk
Unresponsive to verbal stimuli	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Disorientation	Psychiatric disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Mental status changes	Psychiatric disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected73 at risk EG0011 affected78 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected73 at risk EG0015 affected78 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0011 affected78 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Cryptogenic organizing pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected73 at risk EG0012 affected78 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0003 affected73 at risk EG0011 affected78 at risk
Idiopathic pneumonia syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0011 affected78 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0012 affected78 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0011 affected78 at risk
Pulmonary cavitation	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Pulmonary microemboli	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected73 at risk EG0011 affected78 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0011 affected78 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Dermatitis exfoliative	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Exfoliative rash	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Haematoma	Vascular disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0011 affected78 at risk
Hypotension	Vascular disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0011 affected78 at risk
Superior vena caval occlusion	Vascular disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected78 at risk
Thrombosis	Vascular disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected78 at risk
Venoocclusive disease	Vascular disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0012 affected78 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 9.0	Systematic Assessment	EG00014 affected73 at risk EG00113 affected78 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 9.0	Systematic Assessment	EG00024 affected73 at risk EG00124 affected78 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0012 affected78 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 9.0	Systematic Assessment	EG0005 affected73 at risk EG0017 affected78 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 9.0	Systematic Assessment	EG00014 affected73 at risk EG00113 affected78 at risk
Bradycardia	Cardiac disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0013 affected78 at risk
Tachycardia	Cardiac disorders	MedDRA 9.0	Systematic Assessment	EG00016 affected73 at risk EG00120 affected78 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0010 affected78 at risk
Cushingoid	Endocrine disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0012 affected78 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0014 affected78 at risk
Dry eye	Eye disorders	MedDRA 9.0	Systematic Assessment	EG0005 affected73 at risk EG0015 affected78 at risk
Vision blurred	Eye disorders	MedDRA 9.0	Systematic Assessment	EG0009 affected73 at risk EG0019 affected78 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0013 affected78 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG00110 affected78 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG00027 affected73 at risk EG00134 affected78 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0016 affected78 at risk
Abdominal tenderness	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0005 affected73 at risk EG0011 affected78 at risk
Constipation	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG00029 affected73 at risk EG00116 affected78 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG00065 affected73 at risk EG00164 affected78 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG00013 affected73 at risk EG00111 affected78 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG00012 affected73 at risk EG00116 affected78 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG00010 affected73 at risk EG0016 affected78 at risk
Flatulence	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0006 affected73 at risk EG0014 affected78 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0006 affected73 at risk EG0013 affected78 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0003 affected73 at risk EG0015 affected78 at risk
Nausea	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG00070 affected73 at risk EG00171 affected78 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected73 at risk EG0017 affected78 at risk
Oral pain	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0006 affected73 at risk EG0019 affected78 at risk
Paraesthesia oral	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0014 affected78 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0007 affected73 at risk EG0014 affected78 at risk
Tongue coated	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected73 at risk EG0017 affected78 at risk
Tongue disorder	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0016 affected78 at risk
Vomiting	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG00053 affected73 at risk EG00153 affected78 at risk
Asthenia	General disorders	MedDRA 9.0	Systematic Assessment	EG00018 affected73 at risk EG00115 affected78 at risk
Catheter site pain	General disorders	MedDRA 9.0	Systematic Assessment	EG0009 affected73 at risk EG0018 affected78 at risk
Chills	General disorders	MedDRA 9.0	Systematic Assessment	EG00013 affected73 at risk EG0017 affected78 at risk
Face oedema	General disorders	MedDRA 9.0	Systematic Assessment	EG0003 affected73 at risk EG0016 affected78 at risk
Fatigue	General disorders	MedDRA 9.0	Systematic Assessment	EG00047 affected73 at risk EG00154 affected78 at risk
Generalised oedema	General disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected73 at risk EG0015 affected78 at risk
Mucosal inflammation	General disorders	MedDRA 9.0	Systematic Assessment	EG0008 affected73 at risk EG00112 affected78 at risk
Oedema	General disorders	MedDRA 9.0	Systematic Assessment	EG00011 affected73 at risk EG0019 affected78 at risk
Oedema peripheral	General disorders	MedDRA 9.0	Systematic Assessment	EG00030 affected73 at risk EG00126 affected78 at risk
Pain	General disorders	MedDRA 9.0	Systematic Assessment	EG00011 affected73 at risk EG0016 affected78 at risk
Pyrexia	General disorders	MedDRA 9.0	Systematic Assessment	EG00033 affected73 at risk EG00134 affected78 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected73 at risk EG0014 affected78 at risk
Jaundice	Hepatobiliary disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected73 at risk EG0014 affected78 at risk
Graft versus host disease	Immune system disorders	MedDRA 9.0	Systematic Assessment	EG00017 affected73 at risk EG00113 affected78 at risk
BK virus infection	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0003 affected73 at risk EG0014 affected78 at risk
Bacteraemia	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0009 affected73 at risk EG00111 affected78 at risk
Candidiasis	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0002 affected73 at risk EG0018 affected78 at risk
Catheter site infection	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0011 affected78 at risk
Clostridial infection	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0013 affected78 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0002 affected73 at risk EG0014 affected78 at risk
Enterococcal infection	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0015 affected78 at risk
Folliculitis	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0005 affected73 at risk EG0012 affected78 at risk
Oral candidiasis	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0002 affected73 at risk EG0019 affected78 at risk
Pneumonia	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0014 affected78 at risk
Staphylococcal infection	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0006 affected73 at risk EG00110 affected78 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0011 affected78 at risk
Urinary tract infection	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0002 affected73 at risk EG0018 affected78 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 9.0	Systematic Assessment	EG0005 affected73 at risk EG0013 affected78 at risk
Blood bilirubin increased	Investigations	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0014 affected78 at risk
Blood creatinine increased	Investigations	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0011 affected78 at risk
Cytomegalovirus test	Investigations	MedDRA 9.0	Systematic Assessment	EG0003 affected73 at risk EG0016 affected78 at risk
Weight decreased	Investigations	MedDRA 9.0	Systematic Assessment	EG0008 affected73 at risk EG0016 affected78 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG00026 affected73 at risk EG00126 affected78 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG00015 affected73 at risk EG00112 affected78 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0012 affected78 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG0003 affected73 at risk EG0015 affected78 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0012 affected78 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG0008 affected73 at risk EG00116 affected78 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG0008 affected73 at risk EG0012 affected78 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0012 affected78 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG0003 affected73 at risk EG0015 affected78 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG00013 affected73 at risk EG00111 affected78 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG00025 affected73 at risk EG00118 affected78 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0013 affected78 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG00011 affected73 at risk EG00110 affected78 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG00020 affected73 at risk EG00118 affected78 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0006 affected73 at risk EG0012 affected78 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0005 affected73 at risk EG0015 affected78 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0008 affected73 at risk EG0015 affected78 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0007 affected73 at risk EG0016 affected78 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected73 at risk EG0015 affected78 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0005 affected73 at risk EG0013 affected78 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG00015 affected73 at risk EG00115 affected78 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0005 affected73 at risk EG0013 affected78 at risk
Shoulder pain	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0007 affected73 at risk EG0017 affected78 at risk
Dizziness	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG00021 affected73 at risk EG00114 affected78 at risk
Dysgeusia	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0008 affected73 at risk EG0016 affected78 at risk
Headache	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG00038 affected73 at risk EG00146 affected78 at risk
Lethargy	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0014 affected78 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0006 affected73 at risk EG0012 affected78 at risk
Paraesthesia	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0013 affected78 at risk
Sinus headache	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0011 affected78 at risk
Tremor	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG00017 affected73 at risk EG00110 affected78 at risk
Anxiety	Psychiatric disorders	MedDRA 9.0	Systematic Assessment	EG00020 affected73 at risk EG00118 affected78 at risk
Confusional state	Psychiatric disorders	MedDRA 9.0	Systematic Assessment	EG00013 affected73 at risk EG0016 affected78 at risk
Depression	Psychiatric disorders	MedDRA 9.0	Systematic Assessment	EG00011 affected73 at risk EG00110 affected78 at risk
Hallucination	Psychiatric disorders	MedDRA 9.0	Systematic Assessment	EG0008 affected73 at risk EG0015 affected78 at risk
Insomnia	Psychiatric disorders	MedDRA 9.0	Systematic Assessment	EG00029 affected73 at risk EG00128 affected78 at risk
Dysuria	Renal and urinary disorders	MedDRA 9.0	Systematic Assessment	EG0009 affected73 at risk EG00110 affected78 at risk
Haematuria	Renal and urinary disorders	MedDRA 9.0	Systematic Assessment	EG00011 affected73 at risk EG00112 affected78 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0013 affected78 at risk
Renal failure	Renal and urinary disorders	MedDRA 9.0	Systematic Assessment	EG0006 affected73 at risk EG0016 affected78 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0015 affected78 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 9.0	Systematic Assessment	EG0003 affected73 at risk EG0015 affected78 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG00022 affected73 at risk EG00126 affected78 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG00014 affected73 at risk EG00116 affected78 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0005 affected73 at risk EG0013 affected78 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG00017 affected73 at risk EG00113 affected78 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG00110 affected78 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0006 affected73 at risk EG0016 affected78 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0016 affected78 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG00014 affected73 at risk EG0018 affected78 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0003 affected73 at risk EG00111 affected78 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0012 affected78 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0005 affected73 at risk EG0011 affected78 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0006 affected73 at risk EG0013 affected78 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0013 affected78 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0011 affected78 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0013 affected78 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0010 affected78 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG00014 affected73 at risk EG0017 affected78 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0003 affected73 at risk EG0014 affected78 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG00017 affected73 at risk EG00111 affected78 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0011 affected78 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0009 affected73 at risk EG0014 affected78 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG00020 affected73 at risk EG00120 affected78 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG00027 affected73 at risk EG00135 affected78 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG0013 affected78 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected73 at risk EG0014 affected78 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG00110 affected78 at risk
Flushing	Vascular disorders	MedDRA 9.0	Systematic Assessment	EG0005 affected73 at risk EG0014 affected78 at risk
Hypertension	Vascular disorders	MedDRA 9.0	Systematic Assessment	EG00025 affected73 at risk EG00129 affected78 at risk
Hypotension	Vascular disorders	MedDRA 9.0	Systematic Assessment	EG00013 affected73 at risk EG0016 affected78 at risk

ID	Term
D006086	Graft vs Host Disease
D019337	Hematologic Neoplasms
D013280	Stomatitis

ID	Term
D007154	Immune System Diseases
D009371	Neoplasms by Site
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

ID	Term
D051523	Fibroblast Growth Factor 7
D019172	Transplantation Conditioning
D008727	Methotrexate

ID	Term
D005346	Fibroblast Growth Factors
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011506	Proteins
D001685	Biological Factors
D007165	Immunosuppression Therapy
D007167	Immunotherapy
D056747	Immunomodulation
D001691	Biological Therapy
D013812	Therapeutics
D007158	Immunologic Techniques
D008919	Investigative Techniques
D000630	Aminopterin
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.			40	73	71	73
EG001	Palifermin	Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.			50	78	77	78