Cytarabine in Combination With Arsenic Trioxide vs. Cytar... | NCT00513305

Label	Type	Description	Intervention Names
Low-dose cytarabine plus arsenic trioxide	Active Comparator	Cycle 1 cytarabine 10 mg/m^2 was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2 A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.	Drug: Arsenic trioxide Drug: Low-dose cytarabine alone
Low-dose cytarabine alone	Active Comparator	Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine was given to patients with persistent disease. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. Recovery period up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.	Drug: Low-dose cytarabine alone

Name	Type	Description	Arm Group Labels	Other Names
Arsenic trioxide	Drug	Arsenic trioxide will be administered intravenously (iv) at a dose of 0.25 mg/kg.	Low-dose cytarabine plus arsenic trioxide

Measure	Description	Time Frame
Percentage of Participants in Complete Remission (CR)	The primary efficacy variable was the percentage of subjects in each treatment group who achieved complete remission after treatment with study drug. Complete remission was defined as: 1) Less than 5% blasts in normocellular bone marrow sample. 2) No blasts in bone marrow sample containing Auer rods. 3)Clearance of previous extramedullary disease. 4)Normal values for absolute neutrophil count (at least 1000/microliter), platelet count (at least 100,000/microliter), without platelet transfusions, and in absence of peripheral myeloblasts.	From baseline through Day 70. Assessments were performed on Day 21 in cycle 1, no later than Day 56 of cycle 1 or 2 (if applicable), and no later than Day 70 of cycle 1 or 2 (if applicable) or at any other time at the discretion of the investigator

Measure	Description	Time Frame
Number of Participants Who Died or Were Censored by 24 Months	This measure (time to death or censor) was defined for all enrolled subjects from the date of randomization until death from any cause. If a subject was not known to have died by the end of the followup period, observation of overall survival was censored on the date the patient was last known to be alive. The number of participants who died or were censored is presented here. (Note: all subjects participating in this study had either died or were censored by 24 months.)

Facility	Status	City	State	ZIP	Country	Contacts
USC / Norris Cancer Hospital		Los Angeles	California	90033	United States
UCLA Medical Center

ID	Title	Description
FG000	Low-dose Cytarabine Plus Arsenic Trioxide	Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.

ID	Title	Description
BG000	Low-dose Cytarabine Plus Arsenic Trioxide	Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
BG001	Low-dose Cytarabine Alone	Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00033 BG00134 BG00267

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

Percentage of Participants in Complete Remission (CR)

The primary efficacy variable was the percentage of subjects in each treatment group who achieved complete remission after treatment with study drug. Complete remission was defined as: 1) Less than 5% blasts in normocellular bone marrow sample. 2) No blasts in bone marrow sample containing Auer rods. 3)Clearance of previous extramedullary disease. 4)Normal values for absolute neutrophil count (at least 1000/microliter), platelet count (at least 100,000/microliter), without platelet transfusions, and in absence of peripheral myeloblasts.

Intention to treat (ITT) Analysis Set

Posted

Number

Percentage of participants in CR

From baseline through Day 70. Assessments were performed on Day 21 in cycle 1, no later than Day 56 of cycle 1 or 2 (if applicable), and no later than Day 70 of cycle 1 or 2 (if applicable) or at any other time at the discretion of the investigator

ID	Title	Description
OG000	Low-dose Cytarabine Plus Arsenic Trioxide	Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
OG001	Low-dose Cytarabine Alone	Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.

Units	Counts
Participants	OG00033 OG00134

Title

Denominators

Categories

Title	Measurements
	OG00015.2(0.051 to 0.319) OG0018.8(0.019 to 0.0237)

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	The hypothesis of equal complete remission rates between the two treatment groups was tested using a 2-sided, normal approximation to the difference in binomial proportions test with two-sided alpha equal to 0.05.	Chi-squared	There were no adjustments for covariates. Since the primary endpoint was prespecified, no adjustment for multiplicity of endpoints was introduced	0.425	The p-value is from the Pearson chi-square test for testing the equality of two binomial proportions, assuming normal approximation of the binomial proportions.					2-Sided	95						No

Secondary

Number of Participants Who Died or Were Censored by 24 Months

This measure (time to death or censor) was defined for all enrolled subjects from the date of randomization until death from any cause. If a subject was not known to have died by the end of the followup period, observation of overall survival was censored on the date the patient was last known to be alive. The number of participants who died or were censored is presented here. (Note: all subjects participating in this study had either died or were censored by 24 months.)

Posted

Number

Participants

From Baseline through 24 months following Baseline

ID	Title	Description
OG000	Low-dose Cytarabine Plus Arsenic Trioxide	Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.

Secondary

Proportion of Participants With Relapse-Free Survival (RFS)Using the Kaplan-Meier Estimate

RFS is defined for patients who achieved a complete remission (CR), complete remission with incomplete platelet recovery (CRp), or partial remission(PR), and was measured from the date of attaining CR, CRp, or PR until the date of AML relapse or death from any cause, whichever occurred first. For a patient not known to have relapsed or died by the end of the study followup, observation of relapse free survival was censored on the date of the last followup examination. The Kaplan Meier Estimate of relapse-free survival at Month 3 and Month 6 is presented here.

Population analyzed are the subjects who who achieved a complete remission (CR), complete remission with incomplete platelet recovery (CRp), or partial remission(PR)during the course of the study

Posted

Number

95% Confidence Interval

Proportion of participants

From Baseline (randomization) through 24 months following Baseline

ID	Title	Description
OG000	Low-dose Cytarabine Plus Arsenic Trioxide	Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.

Secondary

Number of Participants Who Experienced Early Death

Early death is defined as death from any cause within the first 14 days after start of study drug treatment. The number of patients in each study group who experienced early death is presented here.

Posted

Number

Participants

14 days from start of study drug treatment

ID	Title	Description
OG000	Low-dose Cytarabine Plus Arsenic Trioxide	Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
OG001	Low-dose Cytarabine Alone	Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.

Secondary

Number of Participants Who Experienced Induction (Thirty-Day) Mortality

The number of subjects who died from any cause within the first 30 days after the start of study drug treatment is presented here.

Posted

Number

Participants

Up to 30 days following start of study drug treatment

ID	Title	Description
OG000	Low-dose Cytarabine Plus Arsenic Trioxide	Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
OG001	Low-dose Cytarabine Alone	Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.

Secondary

Proportion of Participants Surviving at 6 Months and 12 Months Using the Kaplan Meier Estimate

The duration of overall survival was defined for all patients and was measured from the date of randomization until death from any cause. For a patient who was not known to have died by the end of the follow-up period, observation of overall survival was censored on the date the patient was last known to be alive. The estimate of likelihood of survival at 6 and 12 months after Baseline using the Kaplan Meier Estimate is presented here.

Posted

Number

95% Confidence Interval

Proportion of Participants

Baseline through 12 months

ID	Title	Description
OG000	Low-dose Cytarabine Plus Arsenic Trioxide	Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected33 at risk
Abscess bacterial	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected33 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected33 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected33 at risk
Asthenia	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0011 events1 affected33 at risk
Bacteraemia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected33 at risk
Capillary leak syndrome	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected33 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected33 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected33 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected33 at risk
Catheter site cellulitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected33 at risk
Cellulitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected33 at risk
Chills	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected33 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0012 events2 affected33 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected33 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected33 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0007 events7 affected33 at risk EG0019 events9 affected33 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected33 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected33 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected33 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected33 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected33 at risk
Hypotension	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0011 events1 affected33 at risk
Infusion related reaction	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected33 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected33 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0012 events2 affected33 at risk
Neutropenic infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected33 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0011 events1 affected33 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected33 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected33 at risk
Pericardial haemorrhage	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected33 at risk
Pneumonia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected33 at risk EG0013 events3 affected33 at risk
Pneumonia fungal	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0010 events0 affected33 at risk
Proctitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected33 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0011 events1 affected33 at risk
Pyrexia	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0011 events1 affected33 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected33 at risk
Renal failure	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0010 events0 affected33 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0012 events2 affected33 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0011 events1 affected33 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0010 events0 affected33 at risk
Sepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0012 events2 affected33 at risk
Septic shock	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected33 at risk
Shock	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected33 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0010 events0 affected33 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected33 at risk
Syncope	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected33 at risk
Tachycardia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected33 at risk
Tumour lysis syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected33 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected33 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected33 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal distension	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0007 events7 affected33 at risk EG0015 events5 affected33 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0007 events7 affected33 at risk EG0014 events4 affected33 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0011 events1 affected33 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0014 events4 affected33 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0011 events1 affected33 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0014 events4 affected33 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0017 events7 affected33 at risk
Asthenia	General disorders	MedDRA 11.1	Systematic Assessment	EG0007 events7 affected33 at risk EG0019 events9 affected33 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0013 events3 affected33 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0006 events6 affected33 at risk EG0013 events3 affected33 at risk
Bacteraemia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0005 events5 affected33 at risk EG0011 events1 affected33 at risk
Blood creatinine increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected33 at risk EG0012 events2 affected33 at risk
Blood culture positive	Investigations	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0011 events1 affected33 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0014 events4 affected33 at risk
Breath sounds abnormal	Investigations	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected33 at risk EG0011 events1 affected33 at risk
Candidiasis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0012 events2 affected33 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0013 events3 affected33 at risk
Cardiac murmur	Investigations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0012 events2 affected33 at risk
Catheter site erythema	General disorders	MedDRA 11.1	Systematic Assessment	EG0004 events4 affected33 at risk EG0010 events0 affected33 at risk
Catheter site pain	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0012 events2 affected33 at risk
Cellulitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0004 events4 affected33 at risk EG0012 events2 affected33 at risk
Chest pain	General disorders	MedDRA 11.1	Systematic Assessment	EG0005 events5 affected33 at risk EG0016 events6 affected33 at risk
Chills	General disorders	MedDRA 11.1	Systematic Assessment	EG0005 events5 affected33 at risk EG0017 events7 affected33 at risk
Clostridial infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0012 events2 affected33 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0012 events2 affected33 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00014 events14 affected33 at risk EG00111 events11 affected33 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0013 events3 affected33 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0007 events7 affected33 at risk EG0017 events7 affected33 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0012 events2 affected33 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00021 events21 affected33 at risk EG00114 events14 affected33 at risk
Dizziness	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0007 events7 affected33 at risk EG0014 events4 affected33 at risk
Dysarthria	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0011 events1 affected33 at risk
Dysgeusia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0010 events0 affected33 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected33 at risk EG0013 events3 affected33 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected33 at risk EG0012 events2 affected33 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0010 events0 affected33 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0013 events3 affected33 at risk
Enterococcal infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0013 events3 affected33 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0012 events2 affected33 at risk
Fatigue	General disorders	MedDRA 11.1	Systematic Assessment	EG00010 events10 affected33 at risk EG0019 events9 affected33 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0009 events9 affected33 at risk EG00116 events16 affected33 at risk
Fungal skin infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0010 events0 affected33 at risk
Generalised oedema	General disorders	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected33 at risk EG0011 events1 affected33 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0004 events4 affected33 at risk EG0012 events2 affected33 at risk
Gout	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0012 events2 affected33 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0015 events5 affected33 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0004 events4 affected33 at risk EG0011 events1 affected33 at risk
Headache	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG00010 events10 affected33 at risk EG0014 events4 affected33 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0004 events4 affected33 at risk EG0014 events4 affected33 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0012 events2 affected33 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected33 at risk EG0010 events0 affected33 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0004 events4 affected33 at risk EG0015 events5 affected33 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0012 events2 affected33 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0004 events4 affected33 at risk EG0016 events6 affected33 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0010 events0 affected33 at risk
Injection site haematoma	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0012 events2 affected33 at risk
Injection site reaction	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0010 events0 affected33 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0012 events2 affected33 at risk
Lip ulceration	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0011 events1 affected33 at risk
Liver function test abnormal	Investigations	MedDRA 11.1	Systematic Assessment	EG0005 events5 affected33 at risk EG0011 events1 affected33 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected33 at risk EG0011 events1 affected33 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0004 events4 affected33 at risk EG0013 events3 affected33 at risk
Mucosal inflammation	General disorders	MedDRA 11.1	Systematic Assessment	EG0004 events4 affected33 at risk EG0012 events2 affected33 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0005 events5 affected33 at risk EG0012 events2 affected33 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0011 events1 affected33 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0014 events4 affected33 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0012 events2 affected33 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00015 events15 affected33 at risk EG0019 events9 affected33 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0011 events1 affected33 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0010 events0 affected33 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected33 at risk EG0013 events3 affected33 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0012 events2 affected33 at risk
Oedema	General disorders	MedDRA 11.1	Systematic Assessment	EG0006 events6 affected33 at risk EG0010 events0 affected33 at risk
Oedema peripheral	General disorders	MedDRA 11.1	Systematic Assessment	EG00016 events16 affected33 at risk EG00114 events14 affected33 at risk
Oral candidiasis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0012 events2 affected33 at risk
Pain	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0012 events2 affected33 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0005 events5 affected33 at risk EG0012 events2 affected33 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0012 events2 affected33 at risk
Paraesthesia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected33 at risk EG0011 events1 affected33 at risk
Pericardial effusion	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0012 events2 affected33 at risk
Pneumonia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0010 events0 affected33 at risk
Pneumonia fungal	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0013 events3 affected33 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0012 events2 affected33 at risk
Pyrexia	General disorders	MedDRA 11.1	Systematic Assessment	EG0009 events9 affected33 at risk EG00112 events12 affected33 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0011 events1 affected33 at risk
Sinusitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0013 events3 affected33 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0013 events3 affected33 at risk
Splenomegaly	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0010 events0 affected33 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0011 events1 affected33 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0012 events2 affected33 at risk
Tachycardia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0006 events6 affected33 at risk EG00110 events10 affected33 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0005 events5 affected33 at risk EG0010 events0 affected33 at risk
Tongue ulceration	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0012 events2 affected33 at risk
Toothache	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0012 events2 affected33 at risk
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0013 events3 affected33 at risk
Tumour lysis syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0012 events2 affected33 at risk
Urinary tract infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0012 events2 affected33 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0012 events2 affected33 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0012 events2 affected33 at risk
Vision blurred	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0011 events1 affected33 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0007 events7 affected33 at risk EG0017 events7 affected33 at risk
Weight decreased	Investigations	MedDRA 11.1	Systematic Assessment	EG0004 events4 affected33 at risk EG0014 events4 affected33 at risk
Weight increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected33 at risk EG0010 events0 affected33 at risk
Anxiety	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0005 events5 affected33 at risk EG0014 events4 affected33 at risk
Insomnia	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0007 events7 affected33 at risk EG0013 events3 affected33 at risk
Confusional state	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0004 events4 affected33 at risk EG0012 events2 affected33 at risk
Depression	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected33 at risk EG0011 events1 affected33 at risk
Mental status changes	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0010 events0 affected33 at risk
Dysuria	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected33 at risk EG0015 events5 affected33 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0014 events4 affected33 at risk
Haematuria	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0013 events3 affected33 at risk
Oliguria	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0013 events3 affected33 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0013 events3 affected33 at risk
Renal failure	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0013 events3 affected33 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0008 events8 affected33 at risk EG0017 events7 affected33 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0009 events9 affected33 at risk EG0017 events7 affected33 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected33 at risk EG0017 events7 affected33 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected33 at risk EG0014 events4 affected33 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0006 events6 affected33 at risk EG0014 events4 affected33 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0013 events3 affected33 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0005 events5 affected33 at risk EG0013 events3 affected33 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0013 events3 affected33 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0012 events2 affected33 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected33 at risk EG0012 events2 affected33 at risk
Lung consolidation	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0012 events2 affected33 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0012 events2 affected33 at risk
Respiratory alkalosis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0012 events2 affected33 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0012 events2 affected33 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected33 at risk EG0011 events1 affected33 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0010 events0 affected33 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0010 events0 affected33 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0010 events0 affected33 at risk
Rhonchi	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected33 at risk EG0010 events0 affected33 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG00010 events10 affected33 at risk EG0016 events6 affected33 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0015 events5 affected33 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0005 events5 affected33 at risk EG0015 events5 affected33 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0008 events8 affected33 at risk EG0014 events4 affected33 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0005 events5 affected33 at risk EG0014 events4 affected33 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0005 events5 affected33 at risk EG0013 events3 affected33 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0013 events3 affected33 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected33 at risk EG0012 events2 affected33 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0006 events6 affected33 at risk EG0012 events2 affected33 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0012 events2 affected33 at risk
Blood blister	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0006 events6 affected33 at risk EG0011 events1 affected33 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0011 events1 affected33 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0010 events0 affected33 at risk
Hypotension	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG00013 events13 affected33 at risk EG0019 events9 affected33 at risk
Haematoma	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0013 events3 affected33 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0012 events2 affected33 at risk
Hypertension	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected33 at risk EG0012 events2 affected33 at risk

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

ID	Term
D001152	Arsenicals
D007287	Inorganic Chemicals
D010087	Oxides
D017601	Oxygen Compounds
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D001087	Arabinonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Low-dose Cytarabine Plus Arsenic Trioxide	Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.			19	33	33	33
EG001	Low-dose Cytarabine Alone	Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.			21	33	33	33