A Study of Clofarabine in Older Patients With Acute Myelo... | NCT00924443

NCT00924443

Status Module

Sponsor/Collaborators Module

Name	Class
Bioenvision	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Clofarabine	Experimental	Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.	Drug: clofarabine

Name	Type	Description	Arm Group Labels	Other Names
clofarabine	Drug		Clofarabine	tradename US = Clolar tradename EU = Evoltra

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Response Rate (ORR)	ORR rate was defined as the sum of the number of participants in the study population with complete remission (CR), complete remission with incomplete blood count recovery (CRi), or partial remission (PR) divided by the total number of participants in the study population. ORR rate was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment. The ORR was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment.	At month 20

Secondary Outcomes

Measure	Description	Time Frame
Rate of Response (Complete, Complete With Incomplete Blood Count Recovery, Partial)	Response was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment. Response was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment.

Eligibility Module

Contacts/Locations Module

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

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

ID	Title	Description
FG000	Clofarabine	Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Baseline Characteristics provided for Full Analysis Set (FAS) population, defined as all participants with a confirmed diagnosis of AML who received at least one dose of clofarabine

Arm/Group Information

ID	Title	Description
BG000	Clofarabine	Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.

Units	Counts
Participants	BG00066

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00071.5± 4.65

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00033
Male	BG00033

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000
Asian	BG0000

Region of Enrollment

Number

participants

Title

Denominators

Categories

Ireland

Title	Measurements
	BG0003

Italy

Title	Measurements
	BG000

Cytogenetics (1998)

Diagnostic criteria of Grimwade for younger patients

Number

participants

Title

Denominators

Categories

Favourable

Title	Measurements
	BG0000

Intermediate

Title	Measurements
	BG000

Cytogenetics (2001)

Diagnostic criteria of Grimwade for older patients

Number

participants

Title

Denominators

Categories

Favourable

Title	Measurements
	BG0000

Intermediate

Title	Measurements
	BG000

Type of Acute Myeloid Leukemia (AML)

Number

participants

Title

Denominators

Categories

De Novo

Title	Measurements
	BG00048

Secondary

Title	Measurements
	BG000

White Blood Cell Count (10^9/L)

Number

participants

Title

Denominators

Categories

<25

Title	Measurements
	BG00057

25-99.9

Title	Measurements
	BG000

Glomerular Filtration Rate (mL/min/1.73m^2)

Number

participants

Title

Denominators

Categories

<=50

Title	Measurements
	BG00015

>50

Title	Measurements
	BG000

Number of Co-morbidities

Number

participants

Title

Denominators

Categories

Title	Measurements
	BG00017

Title	Measurements
	BG000

Karnofsky Performance Status

Karnofsky performance scale is used by doctors to classify patient's functional impairment level. The lower the number the higher the impairment in typical daily activities by the disease.

Typical classification examples: 100% normal with no evidence of disease, 90% able to carry on normal activity with minor signs of illness, 80% normal activity but requiring effort, 70% able to care for self but unable to work or carry on other normal activities, 60% able to care for most needs but requires occasional assistance, 50% considerable assistance and frequent medical care required, etc..

Number

participants

Title

Denominators

Categories

100%

Title	Measurements
	BG0008

90%

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

Overall Response Rate (ORR)

ORR rate was defined as the sum of the number of participants in the study population with complete remission (CR), complete remission with incomplete blood count recovery (CRi), or partial remission (PR) divided by the total number of participants in the study population.

ORR rate was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment. The ORR was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment.

The efficacy analysis was performed on the primary analysis population, the Full Analysis Set population, which consisted of all participants with a diagnosis of AML confirmed by the Investigator who received at least one dose (partial or complete) of clofarabine.

Posted

Number

95% Confidence Interval

percentage of participants

At month 20

ID	Title	Description
OG000	Clofarabine	Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.

Units	Counts
Participants	OG00066

Title

Denominators

Categories

Title	Measurements
	OG00048(36 to 61)

Secondary

Rate of Response (Complete, Complete With Incomplete Blood Count Recovery, Partial)

Response was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment.

Response was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment.

The efficacy analyses were performed on the primary analysis population, the Full Analysis Set population, which consisted of all participants with a diagnosis of AML confirmed by the Investigator who received at least one dose (partial or complete) of clofarabine.

Posted

Number

95% Confidence Interval

percent of participants

At month 20

ID	Title	Description
OG000	Clofarabine	Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.

Units	Counts
Participants	OG000

Secondary

Duration of Overall Response

Duration was calculated by Kaplan-Meier estimates

The analysis were performed on the primary analysis population, the Full Analysis Set population. Defined as the median duration of overall response (CR+CRi+PR) in participants who achieved CR, CRi or PR only

Posted

Median

95% Confidence Interval

days

From 20 months up to 48 months

ID	Title	Description
OG000	Clofarabine	Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.

Units	Counts
Participants	OG000

Secondary

Overall Survival

Calculated by Kaplan-Meier estimates

Posted

Median

95% Confidence Interval

days

From 20 months up to 48 months

ID	Title	Description
OG000	Clofarabine	Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.

Units	Counts
Participants	OG000

Secondary

Duration of Complete Remission

Duration was calculated by Kaplan- Meier estimates

The analysis were performed on the primary analysis population, the Full Analysis Set population. Defined as the median duration of participants who achieved CR+CRi only

Posted

Median

95% Confidence Interval

days

From 20 months up to 48 months

ID	Title	Description
OG000	Clofarabine	Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Clofarabine	Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days(one cycle) and 20 mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for second and subsequent cycles,up to a maximum of 3 cycles.			40	66	66	66

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
PLATELET DISORDER	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0004 affected66 at risk
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
HYPOPITUITARISM	Endocrine disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
ABDOMINAL DISTENSION	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
ILEUS PARALYTIC	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
VOMITING	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
DISEASE PROGRESSION	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
OEDEMA	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
PYREXIA	General disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
BACTERAEMIA	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
BRONCHOPNEUMONIA	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
CATHETER RELATED INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
CENTRAL LINE INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
ENCEPHALITIS HERPES	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
NEUTROPENIC SEPSIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00017 affected66 at risk
PNEUMONIA	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0004 affected66 at risk
RESPIRATORY TRACT INFECTION FUNGAL	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
SEPSIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0005 affected66 at risk
ACCIDENTAL OVERDOSE	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
FALL	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
BLOOD BILIRUBIN INCREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
BLOOD CREATININE INCREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
HAEMOGLOBIN DECREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
HEPATIC ENZYME INCREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
URINE OUTPUT DECREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
PITUITARY TUMOUR	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
CEREBRAL HAEMORRHAGE	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
HAEMORRHAGE INTRACRANIAL	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected66 at risk
HEADACHE	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
SYNCOPE	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
UNRESPONSIVE TO PAIN STIMULI	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
NEPHROTIC SYNDROME	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
RENAL FAILURE ACUTE	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0007 affected66 at risk
RENAL IMPAIRMENT	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
RENAL INSUFFICIENCY	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0005 affected66 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
SKIN DESQUAMATION	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
HYPOTENSION	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
THROMBOSIS	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG00022 affected66 at risk
COAGULOPATHY	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
DISSEMINATED INTRAVASCULAR COAGULATION	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0004 affected66 at risk
HAEMOLYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
LYMPHOPENIA	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG00019 affected66 at risk
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
SPLENOMEGALY	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG00032 affected66 at risk
ARRHYTHMIA SUPRAVENTRICULAR	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0004 affected66 at risk
PALPITATIONS	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
SUPRAVENTRICULAR EXTRASYSTOLES	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
TACHYCARDIA	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
ADRENAL INSUFFICIENCY	Endocrine disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
HYPOTHALAMO-PITUITARY DISORDERS	Endocrine disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
HYPOTHYROIDISM	Endocrine disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
EYE PAIN	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
EYE REDNESS	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
HETEROPHORIA	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
KERATOCONJUNCTIVITIS SICCA	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
LACRIMATION INCREASED	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
VISION BLURRED	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
ABDOMINAL DISTENSION	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00013 affected66 at risk
CHEILITIS	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00027 affected66 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00040 affected66 at risk
DRY MOUTH	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0006 affected66 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0005 affected66 at risk
DYSPHAGIA	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
ERUCTATION	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
FAECALOMA	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
FLATULENCE	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
GINGIVAL PAIN	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
GLOSSODYNIA	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
HAEMATEMESIS	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
HAEMORRHOIDAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
ILEUS PARALYTIC	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
LOOSE STOOLS	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
MELAENA	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
MOUTH ULCERATION	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0006 affected66 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00044 affected66 at risk
OESOPHAGEAL ULCER	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
ORAL MUCOSAL BLISTERING	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
ORAL MUCOSAL PETECHIAE	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
ORAL PAIN	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0005 affected66 at risk
RECTAL PROLAPSE	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
STOMATITIS	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0005 affected66 at risk
SWOLLEN TONGUE	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
TONGUE BLISTERING	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
TONGUE COATED	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected66 at risk
TONGUE ULCERATION	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
TOOTHACHE	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
VOMITING	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00037 affected66 at risk
ASTHENIA	General disorders	MedDRA 16.1	Systematic Assessment	EG0007 affected66 at risk
CATHETER RELATED COMPLICATION	General disorders	MedDRA 16.1	Systematic Assessment	EG00014 affected66 at risk
CATHETER SITE INFLAMMATION	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
CHEST DISCOMFORT	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
CHEST PAIN	General disorders	MedDRA 16.1	Systematic Assessment	EG00011 affected66 at risk
FATIGUE	General disorders	MedDRA 16.1	Systematic Assessment	EG00016 affected66 at risk
GAIT ABNORMAL	General disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
GENERALISED OEDEMA	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
INFLUENZA LIKE ILLNESS	General disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
LOCALISED OEDEMA	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
MASS	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
MUCOSAL INFLAMMATION	General disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
OEDEMA	General disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 16.1	Systematic Assessment	EG00012 affected66 at risk
PAIN	General disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected66 at risk
PITTING OEDEMA	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
PYREXIA	General disorders	MedDRA 16.1	Systematic Assessment	EG00024 affected66 at risk
RIGORS	General disorders	MedDRA 16.1	Systematic Assessment	EG0007 affected66 at risk
TENDERNESS	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
HEPATOTOXICITY	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
HYPERBILIRUBINAEMIA	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0004 affected66 at risk
HYPERSENSITIVITY	Immune system disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
ANAL INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
BACTERIAL INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
BACTERIAL SEPSIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
CELLULITIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0007 affected66 at risk
CENTRAL LINE INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00011 affected66 at risk
CLOSTRIDIAL INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
CLOSTRIDIUM COLITIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
FUNGAL INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
GASTROINTESTINAL CANDIDIASIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
GENITAL INFECTION FEMALE	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
HERPES SIMPLEX	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0003 affected66 at risk
HERPES VIRUS INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0009 affected66 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0004 affected66 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
NEUTROPENIC INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
NEUTROPENIC SEPSIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0003 affected66 at risk
ORAL CANDIDIASIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
PHARYNGITIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
PNEUMONIA	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0003 affected66 at risk
PNEUMONIA FUNGAL	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
RHINITIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
SEPSIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0005 affected66 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
VANCOMYCIN-RESISTANT ENTEROCOCCAL INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
VIRAL INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
BLISTER	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
CONTUSION	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0004 affected66 at risk
FALL	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0003 affected66 at risk
MEDICAL DEVICE DISCOMFORT	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
TRANSFUSION REACTION	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0003 affected66 at risk
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG00021 affected66 at risk
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG00015 affected66 at risk
BACTERIA BLOOD IDENTIFIED	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
BACTERIA STOOL IDENTIFIED	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
BLOOD ALBUMIN DECREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
BLOOD ALKALINE PHOSPHATASE INCREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0005 affected66 at risk
BLOOD BICARBONATE DECREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0004 affected66 at risk
BLOOD BILIRUBIN INCREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0006 affected66 at risk
BLOOD CALCIUM DECREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0003 affected66 at risk
BLOOD CREATININE	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
BLOOD CREATININE ABNORMAL	Investigations	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
BLOOD CREATININE DECREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
BLOOD CREATININE INCREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0008 affected66 at risk
BLOOD LACTATE DEHYDROGENASE INCREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0009 affected66 at risk
BLOOD MAGNESIUM	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
BLOOD MAGNESIUM DECREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
BLOOD MAGNESIUM INCREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
BLOOD PHOSPHORUS DECREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0003 affected66 at risk
BLOOD PHOSPHORUS INCREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
BLOOD POTASSIUM DECREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG00011 affected66 at risk
BLOOD PRESSURE DECREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
BLOOD SODIUM DECREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0003 affected66 at risk
BLOOD SODIUM INCREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
BLOOD UREA DECREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
BLOOD UREA INCREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG00010 affected66 at risk
BODY TEMPERATURE INCREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
CARDIAC MURMUR	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
HAEMOGLOBIN DECREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0006 affected66 at risk
HEART RATE IRREGULAR	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
HEPATIC ENZYME INCREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
LIVER FUNCTION TEST ABNORMAL	Investigations	MedDRA 16.1	Systematic Assessment	EG0003 affected66 at risk
NEUTROPHIL COUNT DECREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
PLATELET COUNT DECREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0006 affected66 at risk
PROTEIN TOTAL DECREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
PROTHROMBIN TIME PROLONGED	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
TROPONIN T INCREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
URINE OUTPUT DECREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
WEIGHT DECREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0003 affected66 at risk
WEIGHT INCREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0004 affected66 at risk
WHITE BLOOD CELL COUNT DECREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
ACIDOSIS	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
ANOREXIA	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG00010 affected66 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG00017 affected66 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0005 affected66 at risk
ELECTROLYTE IMBALANCE	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
FLUID OVERLOAD	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
GOUT	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0004 affected66 at risk
HYPERNATRAEMIA	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
HYPERPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
HYPOALBUMINAEMIA	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0006 affected66 at risk
HYPOCALCAEMIA	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG00011 affected66 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG00023 affected66 at risk
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0004 affected66 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected66 at risk
HYPOPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected66 at risk
METABOLIC ACIDOSIS	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0007 affected66 at risk
ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0006 affected66 at risk
BUTTOCK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
JOINT STIFFNESS	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
JOINT SWELLING	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
MUSCLE CRAMP	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0005 affected66 at risk
NECK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0007 affected66 at risk
BURNING SENSATION	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
CENTRAL NERVOUS SYSTEM INFLAMMATION	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
CEREBRAL ISCHAEMIA	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
DEPRESSED LEVEL OF CONSCIOUSNESS	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
DIZZINESS	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG00011 affected66 at risk
DYSARTHRIA	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
DYSGEUSIA	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected66 at risk
HAEMORRHAGE INTRACRANIAL	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
HEADACHE	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG00014 affected66 at risk
HYPERAESTHESIA	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
HYPOAESTHESIA	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
LETHARGY	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0007 affected66 at risk
PARAESTHESIA	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
POLYNEUROPATHY	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
RESTLESS LEGS SYNDROME	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
SOMNOLENCE	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
SPEECH DISORDER	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
SYNCOPE	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected66 at risk
SYNCOPE VASOVAGAL	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected66 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
AGITATION	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0005 affected66 at risk
ANXIETY	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0007 affected66 at risk
CONFUSIONAL STATE	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0009 affected66 at risk
DEPRESSED MOOD	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
DEPRESSION	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
DISORIENTATION	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
EMOTIONAL DISTRESS	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
HALLUCINATION	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0006 affected66 at risk
INSOMNIA	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0009 affected66 at risk
PANIC ATTACK	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
PSYCHIATRIC SYMPTOM	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
SLEEP DISORDER	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
DYSURIA	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
HAEMATURIA	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0005 affected66 at risk
OLIGURIA	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
POLLAKIURIA	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
RENAL COLIC	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
RENAL FAILURE ACUTE	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected66 at risk
RENAL IMPAIRMENT	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0007 affected66 at risk
RENAL INSUFFICIENCY	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
RENAL TUBULAR DISORDER	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
URINARY INCONTINENCE	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0004 affected66 at risk
BALANITIS	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
PENIS DISORDER	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
VAGINAL HAEMORRHAGE	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
APNOEIC ATTACK	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
CAPILLARY LEAK SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG00013 affected66 at risk
CRACKLES LUNG	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG00014 affected66 at risk
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0008 affected66 at risk
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
HYPOXIA	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
INCREASED UPPER AIRWAY SECRETION	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
LUNG CREPITATION	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0006 affected66 at risk
LUNG INFILTRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
PHARYNGOLARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0008 affected66 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0006 affected66 at risk
PLEURITIC PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected66 at risk
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
PRODUCTIVE COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
RESPIRATORY DISORDER	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
RHINORRHOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
WHEEZING	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0005 affected66 at risk
ALOPECIA	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
DECUBITUS ULCER	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected66 at risk
DERMATITIS ALLERGIC	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
DERMATITIS EXFOLIATIVE	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
ECCHYMOSIS	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0007 affected66 at risk
HYPERHIDROSIS	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected66 at risk
LOCALISED SKIN REACTION	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
NIGHT SWEATS	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
PALMAR ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0007 affected66 at risk
PRURITUS GENERALISED	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
PURPURA	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG00029 affected66 at risk
RASH ERYTHEMATOUS	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected66 at risk
RASH GENERALISED	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
RASH MACULAR	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
RASH MACULO-PAPULAR	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
RASH PAPULAR	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
RASH PRURITIC	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected66 at risk
SWELLING FACE	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
INADEQUATE DIET	Social circumstances	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
FLUSHING	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
HAEMORRHAGE	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected66 at risk
HYPERTENSION	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0007 affected66 at risk
HYPOTENSION	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG00011 affected66 at risk
ORTHOSTATIC HYPOTENSION	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk
PETECHIAE	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0005 affected66 at risk
VENOUS THROMBOSIS LIMB	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected66 at risk

ID	Term
D015470	Leukemia, Myeloid, Acute

ID	Term
D000077866	Clofarabine

Ancestor Terms

ID	Term
D000227	Adenine Nucleotides
D011685	Purine Nucleotides
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D001087	Arabinonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D009711	Nucleotides
D012265	Ribonucleotides

Facility	Status	City	State	ZIP	Country	Contacts
		Dublin			Ireland

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases