Alternative Dosing Regimens of Subcutaneous Azacitidine f... | NCT00102687

Label	Type	Description	Intervention Names
Aza-5	Experimental	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.	Drug: azacitidine
Aza-5-2-2	Experimental	Azacitidine administered subcutaneously at 75mg/m^2 for 5days with 2 days off, then for an additional 2 days, on a 28 day cycle.	Drug: azacitidine
Aza-5-2-5	Experimental	Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.	Drug: azacitidine
Maintenance Aza 5 days q 4 weeks	Experimental	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks.	Drug: azacitidine
Maintenance Aza 5 days q 6 weeks	Experimental	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks.	Drug: azacitidine

Name	Type	Description	Arm Group Labels	Other Names
azacitidine	Drug	Azacitidine is administered subcutaneously Total of 18 cycles on treatment or early discontinuation.	Aza-5 Aza-5-2-2 Aza-5-2-5

Measure	Description	Time Frame
Number of Participants In Best Hematological Response Categories as Determined by the Investigator Using International Working Group 2000 (IWG 2000) Criteria For Myelodysplastic Syndromes (MDS) During the Initial Study Period.	Participant counts by best hematological response; complete remission(CR) is better than a partial remission(PR) which is better than stable disease(SD). Investigator determined responses followed IWG 2000 criteria for MDS CR: repeat bone marrow show <5% myeloblasts, and peripheral blood evaluations lasting >=2 months of hemoglobin(>110 g/L), neutrophils(>=1.5x10^9/L), platelets(>=100x10^9/L), blasts (0%) and no dysplasia PR is the same as CR for peripheral blood: bone marrow shows blasts decrease by >=50% or a less advanced FAB classification from pretreatment (see Population Descrip)	Day 1 (randomization) to 6 months
Number of Participants With Best Hematological Improvement Derived Using International Working Group 2000 (IWG 2000) Criteria for MDS During the Initial Study Period.	IWG 2000 Criteria: Pretreatment=hemoglobin <110g/L or RBC transfusion-dependence, platelet count <100x10^9/L or platelet transfusion dependence, absolute neutrophil count <1.5x10^9/L. Erythroid response: Major->20g/L increase in hemoglobin or transfusion independence. Minor- 10-20g/L increase in hemoglobin or >=50% decrease in transfusion requirements. Platelet response: Major-absolute increase of platelet count by >=30x10^9/L or platelet transfusion independence. Minor->=50% increase in platelet count with net increase >10x10^9/L but <30x10^9/L. (continued in Population Description)	Day 1 (randomization) to 6 months
Number of Participants With Overall Best Hematologic Response and Hematologic Improvement Based on IWG 2000 Criteria For MDS During the Initial Study Period	Number of participants whose best hematological outcome was either complete remission (CR), partial remission (PR) (as determined by the investigator), or any hematologic improvement (based on the IWG 2000 criteria for MDS). See previous outcomes for detailed definitions.	Day 1 (randomization) to 6 months

Measure	Description	Time Frame
Baseline Hemoglobin Values	The median values for hemoglobin based on blood tests performed on study day 1 (prior to study treatment) constitute a baseline measure for hemoglobin. Baseline values are used to compare to values following treatment.	Day 1 (randomization)
Change From Baseline in Hemoglobin at End of Initial Study Period (6 Months)

Name	Affiliation	Role
CL Beach	Celgene Corporation	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Comprehensive Blood and Cancer Center, Research Department		Bakersfield	California	93309	United States

PubMed Identifier	Type	Citation
	Background	R. Lyons, et al. Rapid onset of effectiveness with three alternative azacitidine (aza) dosing regimens in patients (pts) with myelodysplastic syndromes (MDS). Haematologica 2008;93(suppl 1):Abs.0232.
	Background	Lyons R, et al. Tolerability and hematologic improvement assessed using three alternative dosing schedules of azacitidine in patients with myelodysplastic syndromes. Presented at the 2007 ASCO Annual Meeting, June 1-5, 2007, Chicago, IL. Abstract No. 7083
29118268	Background	Komrokji R, Swern AS, Grinblatt D, Lyons RM, Tobiasson M, Silverman LR, Sayar H, Vij R, Fliss A, Tu N, Sugrue MM. Azacitidine in Lower-Risk Myelodysplastic Syndromes: A Meta-Analysis of Data from Prospective Studies. Oncologist. 2018 Feb;23(2):159-170. doi: 10.1634/theoncologist.2017-0215. Epub 2017 Nov 8.

ID	Title	Description
FG000	Aza-5	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
FG001	Aza-5-2-2	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.

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

Number of Participants In Best Hematological Response Categories as Determined by the Investigator Using International Working Group 2000 (IWG 2000) Criteria For Myelodysplastic Syndromes (MDS) During the Initial Study Period.

Participant counts by best hematological response; complete remission(CR) is better than a partial remission(PR) which is better than stable disease(SD).

Investigator determined responses followed IWG 2000 criteria for MDS CR: repeat bone marrow show <5% myeloblasts, and peripheral blood evaluations lasting >=2 months of hemoglobin(>110 g/L), neutrophils(>=1.5x10^9/L), platelets(>=100x10^9/L), blasts (0%) and no dysplasia PR is the same as CR for peripheral blood: bone marrow shows blasts decrease by >=50% or a less advanced FAB classification from pretreatment (see Population Descrip)

Intent to treat population. Patients without a second bone marrow assessment could not be evaluated for hematologic response.

(Outcome Description continued)SD is a failure to achieve at least a PR, but with no evidence of progression for at least 2 months.

Posted

Number

participants

Day 1 (randomization) to 6 months

ID	Title	Description
OG000	Aza-5	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
OG001	Aza-5-2-2	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
OG002	Aza-5-2-5	Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.

Units	Counts
Participants	OG00050 OG00150 OG00251

Title

Denominators

Categories

Overall Response (CR+PR)

Title	Measurements
	OG0004 OG0013 OG0024

Complete remission (CR)

Primary

Number of Participants With Best Hematological Improvement Derived Using International Working Group 2000 (IWG 2000) Criteria for MDS During the Initial Study Period.

IWG 2000 Criteria: Pretreatment=hemoglobin <110g/L or RBC transfusion-dependence, platelet count <100x10^9/L or platelet transfusion dependence, absolute neutrophil count <1.5x10^9/L.

Erythroid response: Major->20g/L increase in hemoglobin or transfusion independence. Minor- 10-20g/L increase in hemoglobin or >=50% decrease in transfusion requirements.

Platelet response: Major-absolute increase of platelet count by >=30x10^9/L or platelet transfusion independence. Minor->=50% increase in platelet count with net increase >10x10^9/L but <30x10^9/L.

(continued in Population Description)

Intent to treat population. Patients count only once for best response within an improvement category.

(Outcome Description continued) Neutrophil response: Major->=100% increase in neutrophil count or an absolute increase of >0.5x10^9/L. Minor->=100% increase but an absolute increase of <0.5x10^9/L.

Posted

Number

participants

Day 1 (randomization) to 6 months

ID	Title	Description
OG000	Aza-5	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
OG001	Aza-5-2-2	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.

Primary

Number of Participants With Overall Best Hematologic Response and Hematologic Improvement Based on IWG 2000 Criteria For MDS During the Initial Study Period

Number of participants whose best hematological outcome was either complete remission (CR), partial remission (PR) (as determined by the investigator), or any hematologic improvement (based on the IWG 2000 criteria for MDS). See previous outcomes for detailed definitions.

Intent to treat population

Posted

Number

participants

Day 1 (randomization) to 6 months

ID	Title	Description
OG000	Aza-5	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
OG001	Aza-5-2-2	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
OG002	Aza-5-2-5	Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.

Units

Secondary

Baseline Hemoglobin Values

The median values for hemoglobin based on blood tests performed on study day 1 (prior to study treatment) constitute a baseline measure for hemoglobin. Baseline values are used to compare to values following treatment.

Intent to treat population

Posted

Median

Full Range

g/L

Day 1 (randomization)

ID	Title	Description
OG000	Aza-5	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
OG001	Aza-5-2-2	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
OG002	Aza-5-2-5	Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.

Units	Counts
Participants

Secondary

Change From Baseline in Hemoglobin at End of Initial Study Period (6 Months)

The difference between hemoglobin values at the end of the initial study period minus the hemoglobin values at baseline.

Intent to treat population

Posted

Median

Full Range

g/L

6 months

ID	Title	Description
OG000	Aza-5	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
OG001	Aza-5-2-2	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
OG002	Aza-5-2-5	Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.

Units	Counts
Participants

Primary

Number of Participants Who Improved or Maintained The Hematologic Response From the Initial Study Period (Based on IWG 2000 Criteria For MDS) During the Maintenance Period

Hematologic response during the maintenance period are compared to the response in the initial study period. Initial response could have been a complete remission, a partial remission, stable disease or a hematologic improvement. Maintenance period best response is after randomization to a maintenance arm for those randomized, and is after the start of cycle 7 for those remaining on initial period treatment throughout the study.

Intent to treat population.

Posted

Number

participants

24 months

ID	Title	Description
OG000	Maintenance Aza 5 Days q 4 Weeks	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23
OG001	Maintenance Aza 5 Days q 6 Weeks	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23
OG002	Initial Period Treatment Continued Into Maintenance	Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.

Secondary

Change From Baseline in Hemoglobin at the End of the Maintenance Study Period

The difference between hemoglobin values at the end of the maintenance study period minus the hemoglobin values at baseline.

Intent to treat population

Posted

Median

Full Range

g/L

24 months

ID	Title	Description
OG000	Maintenance Aza 5 Days q 4 Weeks	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23
OG001	Maintenance Aza 5 Days q 6 Weeks	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23
OG002	Initial Period Treatment Continued Into Maintenance	Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.

Units	Counts
Participants

Secondary

Baseline Platelet Values

The median values for platelets based on blood tests performed on study day 1 (prior to study treatment) constitute a baseline measure for platelets. Baseline values are used to compare to values following treatment.

Intent to treat population

Posted

Median

Full Range

x10(9)/L

Day 1 (randomization)

ID	Title	Description
OG000	Aza-5	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
OG001	Aza-5-2-2	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
OG002	Aza-5-2-5	Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.

Units	Counts
Participants

Secondary

Change From Baseline in Platelets at the End of Initial Study Period (6 Months)

The difference between platelet values at the end of the initial study period minus the platelet values at baseline.

Intent to treat population

Posted

Median

Full Range

x10^9/L

6 months

ID	Title	Description
OG000	Aza-5	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
OG001	Aza-5-2-2	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
OG002	Aza-5-2-5	Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.

Units	Counts
Participants

Secondary

Change From Baseline in Platelets at the End of the Maintenance Study Period (Month 24)

The difference between platelet values at the end of the maintenance study period minus the platelet values at baseline.

Intent to treat population

Posted

Median

Full Range

x10^9/L

24 months

ID	Title	Description
OG000	Maintenance Aza 5 Days q 4 Weeks	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23.
OG001	Maintenance Aza 5 Days q 6 Weeks	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23.
OG002	Initial Period Treatment Continued Into Maintenance	Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.

Units	Counts
Participants

Secondary

Baseline Absolute Neutrophil Count (ANC) Values

The median values for ANC based on blood tests performed on study day 1 (prior to study treatment) constitute a baseline measure for ANC. Baseline values are used to compare to values following treatment.

Intent to treat population

Posted

Median

Full Range

x10^9/L

Day 1 (randomization)

ID	Title	Description
OG000	Aza-5	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
OG001	Aza-5-2-2	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
OG002	Aza-5-2-5	Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.

Units	Counts
Participants

Secondary

Change From Baseline in Absolute Neutrophil Count (ANC) at the End of Initial Study Period (6 Months)

The difference between ANC values at the end of the initial study period minus the ANC values at baseline.

Intent to treat population

Posted

Median

Full Range

x10^9/L

6 months

ID	Title	Description
OG000	Aza-5	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
OG001	Aza-5-2-2	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
OG002	Aza-5-2-5	Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.

Units	Counts
Participants

Secondary

Change From Baseline in Absolute Neutrophil Count (ANC) at the End of the Maintenance Study Period (Month 24)

The difference between ANC values at the end of the maintenance study period minus the ANC values at baseline.

Intent to treat population

Posted

Median

Full Range

x10^9/L

24 months

ID	Title	Description
OG000	Maintenance Aza 5 Days q 4 Weeks	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23.
OG001	Maintenance Aza 5 Days q 6 Weeks	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23.
OG002	Initial Period Treatment Continued Into Maintenance	Combines participants who continued their treatment assigned during the initial study period through month 7 to month 23.

Units	Counts
Participants

Secondary

Red Blood Cell (RBC) Transfusion Status at Baseline and End of Initial Study Period (6 Months)

Shift table comparing the RBC transfusion status of patients at the end of the initial study period to the transfusion status at baseline.

Intent to treat population

Posted

Number

participants

6 months

ID	Title	Description
OG000	Aza-5	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
OG001	Aza-5-2-2	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
OG002	Aza-5-2-5	Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.

Units	Counts
Participants

Secondary

Platelet Transfusion Status at Baseline and End of Initial Study Period (6 Months)

Shift table comparing the platelet transfusion status of patients at the end of the initial study period to the transfusion status at baseline.

Intent to treat population

Posted

Number

participants

6 months

ID	Title	Description
OG000	Aza-5	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
OG001	Aza-5-2-2	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
OG002	Aza-5-2-5	Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.

Units	Counts
Participants

Secondary

Red Blood Cell (RBC) Transfusion Status at Baseline and End of Maintenance Study Period (24 Months)

Shift table comparing the RBC transfusion status of patients at the end of the maintenance study period to the transfusion status at baseline.

Intent to treat population

Posted

Number

participants

24 months

ID	Title	Description
OG000	Maintenance Aza 5 Days q 4 Weeks	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23.
OG001	Maintenance Aza 5 Days q 6 Weeks	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23.
OG002	Initial Period Treatment Continued Into Maintenance	Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.

Units	Counts
Participants

Secondary

Platelet Transfusion Status at Baseline and End of Maintenance Study Period (24 Months)

Shift table comparing the platelet transfusion status of patients at the end of the maintenance study period to the transfusion status at baseline.

Intent to treat population

Posted

Number

participants

24 months

ID	Title	Description
OG000	Maintenance Aza 5 Days q 4 Weeks	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23
OG001	Maintenance Aza 5 Days q 6 Weeks	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23
OG002	Initial Period Treatment Continued Into Maintenance	Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.

Units	Counts
Participants

Secondary

Change From Baseline in the Number of Infections Requiring Treatment With IV Antibiotics Per Treatment Cycle (28 Days) for the Initial Study Period

Baseline uses the average number of infections requiring IV antibiotic treatment from the 28 days prior to and including the day of first dose to an initial treatment arm. Initial study period values total the number of infections requiring IV antibiotic treatment divided by the number of treatment cycles (each cycle is approximately one month).

Intent to treat population

Posted

Median

Full Range

infections per cycle

6 months

ID	Title	Description
OG000	Aza-5	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
OG001	Aza-5-2-2	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
OG002	Aza-5-2-5	Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.

Secondary

Change From Baseline in the Number of Infections Requiring Treatment With IV Antibiotics Per Treatment Cycle (28 Days) for the Maintenance Study Period

Baseline uses the average number of infections requiring IV antibiotic treatment from the 28 days prior to and including the day of first dose to an initial treatment arm. Maintenance study period values total the number of infections requiring IV antibiotic treatment divided by the number of treatment cycles (each cycle is approximately one month).

Intent to treat population

Posted

Median

Full Range

infections per cycle

24 months

ID	Title	Description
OG000	Maintenance Aza 5 Days q 4 Weeks	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23.
OG001	Maintenance Aza 5 Days q 6 Weeks	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23.
OG002	Initial Period Treatment Continued Into Maintenance	Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected50 at risk EG0015 affected50 at risk EG0021 affected48 at risk EG0030 affected22 at risk EG0043 affected21 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected50 at risk EG0012 affected50 at risk EG0023 affected48 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0022 affected48 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0012 affected50 at risk EG0020 affected48 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0021 affected48 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Bradycardia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0012 affected50 at risk EG0022 affected48 at risk EG003
Cardiac valve vegetation	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0021 affected48 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Colonic polyp	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0021 affected48 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0021 affected48 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0021 affected48 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0021 affected48 at risk EG003
Gastritis erosive	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0011 affected50 at risk EG0021 affected48 at risk EG003
Inguinal hernia, obstructive	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0021 affected48 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Intussusception	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Oesophageal ulcer	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0021 affected48 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Chest pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0021 affected48 at risk EG003
Fatigue	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Gait disturbance	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Pyrexia	General disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Bronchitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Candida sepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Catheter related infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0021 affected48 at risk EG003
Catheter site cellulitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Cellulitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0011 affected50 at risk EG0021 affected48 at risk EG003
Diverticulitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Enterobacter bacteraemia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Enterococcal sepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Escherichia bacteraemia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Fungal oesophagitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Herpes zoster disseminated	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Incision site cellulitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Lobar pneumonia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0012 affected50 at risk EG0022 affected48 at risk EG003
Lung infection pseudomonal	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Oesophageal candidiasis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Oral herpes	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0021 affected48 at risk EG003
Pneumonia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0011 affected50 at risk EG0025 affected48 at risk EG003
Pseudomonal sepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Rectal abscess	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Sepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0021 affected48 at risk EG003
Septic shock	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0021 affected48 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0021 affected48 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0024 affected48 at risk EG003
Urinary tract infection enterococcal	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Burns second degree	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0021 affected48 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0021 affected48 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0021 affected48 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0011 affected50 at risk EG0021 affected48 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0021 affected48 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0021 affected48 at risk EG003
Hypovolaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0021 affected48 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0021 affected48 at risk EG003
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0014 affected50 at risk EG0020 affected48 at risk EG003
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Carcinoid tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0021 affected48 at risk EG003
Chloroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0021 affected48 at risk EG003
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0003 affected50 at risk EG0010 affected50 at risk EG0021 affected48 at risk EG003
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Non-small cell lung cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Small cell lung cancer stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Dysarthria	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Headache	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Normal pressure hydrocephalus	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Syncope	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Confusional state	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Calculus urinary	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Vaginal polyp	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0021 affected48 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG00011 affected50 at risk EG00117 affected50 at risk EG00212 affected48 at risk EG0033 affected22 at risk EG0045 affected21 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0013 affected50 at risk EG0022 affected48 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0008 affected50 at risk EG00110 affected50 at risk EG0029 affected48 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected50 at risk EG0013 affected50 at risk EG0021 affected48 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG00015 affected50 at risk EG00122 affected50 at risk EG00217 affected48 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG00012 affected50 at risk EG00114 affected50 at risk EG00212 affected48 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected50 at risk EG0010 affected50 at risk EG0023 affected48 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0007 affected50 at risk EG0017 affected50 at risk EG0026 affected48 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00028 affected50 at risk EG00125 affected50 at risk EG00221 affected48 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00013 affected50 at risk EG00115 affected50 at risk EG00214 affected48 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0016 affected50 at risk EG0023 affected48 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected50 at risk EG0013 affected50 at risk EG0021 affected48 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00031 affected50 at risk EG00131 affected50 at risk EG00223 affected48 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0014 affected50 at risk EG0023 affected48 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00018 affected50 at risk EG00112 affected50 at risk EG00213 affected48 at risk EG003
Asthenia	General disorders	MedDRA (10.0)	Systematic Assessment	EG00010 affected50 at risk EG0018 affected50 at risk EG0028 affected48 at risk EG003
Chest pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0015 affected50 at risk EG0021 affected48 at risk EG003
Chills	General disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected50 at risk EG0013 affected50 at risk EG0022 affected48 at risk EG003
Fatigue	General disorders	MedDRA (10.0)	Systematic Assessment	EG00025 affected50 at risk EG00130 affected50 at risk EG00229 affected48 at risk EG003
Gait disturbance	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0013 affected50 at risk EG0021 affected48 at risk EG003
Injection site bruising	General disorders	MedDRA (10.0)	Systematic Assessment	EG00011 affected50 at risk EG0019 affected50 at risk EG0023 affected48 at risk EG003
Injection site desquamation	General disorders	MedDRA (10.0)	Systematic Assessment	EG0007 affected50 at risk EG0012 affected50 at risk EG0023 affected48 at risk EG003
Injection site erythema	General disorders	MedDRA (10.0)	Systematic Assessment	EG00028 affected50 at risk EG00128 affected50 at risk EG00226 affected48 at risk EG003
Injection site haemorrhage	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected50 at risk EG0024 affected48 at risk EG003
Injection site inflammation	General disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected50 at risk EG0011 affected50 at risk EG0024 affected48 at risk EG003
Injection site nodule	General disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected50 at risk EG0011 affected50 at risk EG0023 affected48 at risk EG003
Injection site pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG00015 affected50 at risk EG00118 affected50 at risk EG00218 affected48 at risk EG003
Injection site pruritus	General disorders	MedDRA (10.0)	Systematic Assessment	EG00012 affected50 at risk EG0016 affected50 at risk EG0024 affected48 at risk EG003
Injection site rash	General disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected50 at risk EG0016 affected50 at risk EG0024 affected48 at risk EG003
Injection site urticaria	General disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected50 at risk EG0011 affected50 at risk EG0020 affected48 at risk EG003
Injection site warmth	General disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected50 at risk EG0012 affected50 at risk EG0022 affected48 at risk EG003
Oedema peripheral	General disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected50 at risk EG00114 affected50 at risk EG00216 affected48 at risk EG003
Pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected50 at risk EG0011 affected50 at risk EG0022 affected48 at risk EG003
Pyrexia	General disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected50 at risk EG00112 affected50 at risk EG00210 affected48 at risk EG003
Cellulitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0013 affected50 at risk EG0021 affected48 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0013 affected50 at risk EG0020 affected48 at risk EG003
Oral herpes	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0003 affected50 at risk EG0013 affected50 at risk EG0022 affected48 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0013 affected50 at risk EG0021 affected48 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0009 affected50 at risk EG0014 affected50 at risk EG0026 affected48 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0007 affected50 at risk EG0017 affected50 at risk EG0027 affected48 at risk EG003
Excoriation	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0012 affected50 at risk EG0023 affected48 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0003 affected50 at risk EG0012 affected50 at risk EG0022 affected48 at risk EG003
Blood bilirubin increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0023 affected48 at risk EG003
Blood urea increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0013 affected50 at risk EG0022 affected48 at risk EG003
Weight decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected50 at risk EG0024 affected48 at risk EG003
Anorexia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected50 at risk EG00113 affected50 at risk EG0026 affected48 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected50 at risk EG0012 affected50 at risk EG0025 affected48 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0014 affected50 at risk EG0022 affected48 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected50 at risk EG0018 affected50 at risk EG0022 affected48 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected50 at risk EG0015 affected50 at risk EG0020 affected48 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0014 affected50 at risk EG0021 affected48 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0006 affected50 at risk EG0018 affected50 at risk EG0024 affected48 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected50 at risk EG0013 affected50 at risk EG0024 affected48 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected50 at risk EG0013 affected50 at risk EG0021 affected48 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0013 affected50 at risk EG0022 affected48 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected50 at risk EG0013 affected50 at risk EG0023 affected48 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected50 at risk EG0013 affected50 at risk EG0022 affected48 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected50 at risk EG0011 affected50 at risk EG0022 affected48 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected50 at risk EG0012 affected50 at risk EG0020 affected48 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected50 at risk EG0016 affected50 at risk EG0023 affected48 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected50 at risk EG0014 affected50 at risk EG0022 affected48 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Dizziness	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG00011 affected50 at risk EG00112 affected50 at risk EG00211 affected48 at risk EG003
Headache	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG00013 affected50 at risk EG0014 affected50 at risk EG0027 affected48 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected50 at risk EG0010 affected50 at risk EG0021 affected48 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected50 at risk EG0013 affected50 at risk EG0020 affected48 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected50 at risk EG0012 affected50 at risk EG0020 affected48 at risk EG003
Syncope	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0011 affected50 at risk EG0023 affected48 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected50 at risk EG0015 affected50 at risk EG0024 affected48 at risk EG003
Depression	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected50 at risk EG0018 affected50 at risk EG0024 affected48 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0008 affected50 at risk EG0019 affected50 at risk EG0025 affected48 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0012 affected50 at risk EG0023 affected48 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0013 affected50 at risk EG0020 affected48 at risk EG003
Urinary hesitation	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0024 affected48 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0008 affected50 at risk EG0017 affected50 at risk EG0025 affected48 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG00017 affected50 at risk EG00111 affected50 at risk EG0029 affected48 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0007 affected50 at risk EG0012 affected50 at risk EG0026 affected48 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0007 affected50 at risk EG0013 affected50 at risk EG0021 affected48 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected50 at risk EG0013 affected50 at risk EG0021 affected48 at risk EG003
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected50 at risk EG0016 affected50 at risk EG0025 affected48 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0014 affected50 at risk EG0020 affected48 at risk EG003
Postnasal drip	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0013 affected50 at risk EG0021 affected48 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected50 at risk EG0014 affected50 at risk EG0022 affected48 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected50 at risk EG0013 affected50 at risk EG0021 affected48 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected50 at risk EG0013 affected50 at risk EG0020 affected48 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected50 at risk EG0015 affected50 at risk EG0023 affected48 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected50 at risk EG0018 affected50 at risk EG0026 affected48 at risk EG003
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0007 affected50 at risk EG0012 affected50 at risk EG0021 affected48 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00012 affected50 at risk EG0018 affected50 at risk EG0024 affected48 at risk EG003
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Hypertension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected50 at risk EG0020 affected48 at risk EG003
Hypotension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected50 at risk EG0016 affected50 at risk EG0022 affected48 at risk EG003
Pallor	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected50 at risk EG0012 affected50 at risk EG0021 affected48 at risk EG003

ID	Term
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D001372	Aza Compounds
D009930	Organic Chemicals
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D012263	Ribonucleosides

ID	Title	Description
BG000	Aza-5	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
BG001	Aza-5-2-2	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
BG002	Aza-5-2-5	Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Aza-5	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.	18	50	49	50
EG001	Aza-5-2-2	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.	27	50	50	50
EG002	Aza-5-2-5	Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.	22	48	46	48
EG003	Maintenance Aza 5 Days q 4 Weeks	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23	7	22	18	22
EG004	Maintenance Aza 5 Days q 6 Weeks	Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23	13	21	18	21