Combination Study of Deferasirox and Erythropoietin in Pa... | NCT01868477

NCT01868477

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Erythropoietin alpha	Experimental	Patients will receive erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement is inadequate, dose will be escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement in inadequate, patients will be switched to the combination arm. At any time when erythroid response is achieved, erythropoietin treatment will be stopped until end of study.	Drug: Erythropoietin alpha
Deferasirox + Erythropoietin alpha	Experimental	Patients will receive deferasirox dispersible tablet (DT) 10 mg/kg/day or deferasirox film-coated tablet (FCT) 7 mg/kg/day in combination with erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement is inadequate, erythropoietin dose will be escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement in inadequate, patients will be discontinued from the study. At any time when erythroid response is achieved, erythropoietin treatment will be stopped until end of study. Patients will continue deferasirox treatment.	Drug: Deferasirox DFX, DT Drug: Deferasirox DFX, FCT

Name	Type	Description	Arm Group Labels	Other Names
Deferasirox DFX, DT	Drug	provided as dispersible tablets for oral use in 125 and 250, 500 mg	Deferasirox + Erythropoietin alpha

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference in Percentage of Patients Achieving Erythroid Response Within 12 Weeks, by Treatment Group (Full Analysis Set)	Difference in percentage of patients achieving an erythroid response within 12 weeks of treatment between the two arms according to modified IWG 2006 criteria increase in hemoglobin (Hb) ≥ 1.5 g/dL. Erythroid response is defined as the increase in Hb from baseline ≥ 1.5 g/dL. Patients achieving erythroid response at least once within 12 weeks were considered responders	Baseline up to 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Absolute Change From Baseline to Post-baseline Value for Hemoglobin(g/dL)(Full Analysis Set)	Hematological response criteria defined as: Erythroid response: hemoglobin (Hb) increase from baseline >= 1.5 g/dL (baseline < 11 g/dL), neutrophil response: increase from baseline >= 100% and increase > 0.5 × 10^9/L (baseline <1 × 10^9/L), platelet response: increase from baseline >= 30 × 10^9/L (baseline <100 × 10^9/L) according to modified IWG 2006 criteria

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Oran		31000	Algeria
Novartis Investigative Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Erythropoietin Alpha	Starting dose was erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement was inadequate, dose was escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement was inadequate, participants were switched to the combination arm. At any time when erythroid response was achieved, erythropoietin treatment was stopped until end of study.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 6, 2015	Mar 21, 2018

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Erythropoietin Alpha	Starting dose was erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement was inadequate, dose was escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement was inadequate, participants were switched to the combination arm. At any time when erythroid response was achieved, erythropoietin treatment was stopped until end of study.
BG001	Deferasirox + Erythropoietin Alpha	Starting dose was deferasirox dispersible tablet (DT) 10 mg/kg/day or deferasirox film-coated tablet FCT) 7 mg/kg/day in combination with erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement was inadequate, erythropoietin dose was escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement was inadequate, participants were discontinued from the study. At any time when erythroid response was achieved, erythropoietin treatment was stopped study and Deferasirox treatment was continued until end of study
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00074.5± 5.84 BG00171.1± 7.54 BG00272.9± 6.77

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0008 BG0015 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Caucasian

Title	Measurements
	BG0008 BG0017 BG002

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

Difference in Percentage of Patients Achieving Erythroid Response Within 12 Weeks, by Treatment Group (Full Analysis Set)

Difference in percentage of patients achieving an erythroid response within 12 weeks of treatment between the two arms according to modified IWG 2006 criteria increase in hemoglobin (Hb) ≥ 1.5 g/dL. Erythroid response is defined as the increase in Hb from baseline ≥ 1.5 g/dL. Patients achieving erythroid response at least once within 12 weeks were considered responders

Posted

Number

95% Confidence Interval

percentage of participants

Baseline up to 12 weeks

ID	Title	Description
OG000	Erythropoietin Alpha	Starting dose was erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement was inadequate, dose was escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement was inadequate, participants were switched to the combination arm. At any time when erythroid response was achieved, erythropoietin treatment was stopped until end of study.
OG001	Deferasirox + Erythropoietin Alpha	Starting dose was deferasirox dispersible tablet (DT) 10 mg/kg/day or deferasirox film-coated tablet FCT) 7 mg/kg/day in combination with erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement was inadequate, erythropoietin dose was escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement was inadequate, participants were discontinued from the study. At any time when erythroid response was achieved, erythropoietin treatment was stopped study and Deferasirox treatment was continued until end of study

Units	Counts
Participants	OG00012 OG00111

Title

Denominators

Categories

Title	Measurements
	OG00041.7(15.2 to 72.3) OG00127.3(6.02 to 61.0)

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						Mean Difference (Final Values)	14.4			2-Sided	95	-24.0	48.16					Other	difference

Secondary

Absolute Change From Baseline to Post-baseline Value for Hemoglobin(g/dL)(Full Analysis Set)

Hematological response criteria defined as: Erythroid response: hemoglobin (Hb) increase from baseline >= 1.5 g/dL (baseline < 11 g/dL), neutrophil response: increase from baseline >= 100% and increase > 0.5 × 10^9/L (baseline <1 × 10^9/L), platelet response: increase from baseline >= 30 × 10^9/L (baseline <100 × 10^9/L) according to modified IWG 2006 criteria

Posted

Mean

Standard Deviation

g/dL

Baseline up to 24 weeks

ID	Title	Description
OG000	Erythropoietin Alpha	Starting dose was erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement was inadequate, dose was escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement was inadequate, participants were switched to the combination arm. At any time when erythroid response was achieved, erythropoietin treatment was stopped until end of study.
OG001	Deferasirox + Erythropoietin Alpha	Starting dose was deferasirox dispersible tablet (DT) 10 mg/kg/day or deferasirox film-coated tablet FCT) 7 mg/kg/day in combination with erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement was inadequate, erythropoietin dose was escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement was inadequate, participants were discontinued from the study. At any time when erythroid response was achieved, erythropoietin treatment was stopped study and Deferasirox treatment was continued until end of study

Secondary

Summary of Hematologic Improvement in Patients Randomized to EPO+DFX and EPO Alone, Within 24 Weeks of Treatment (Full Analysis Set)

Percentage of participants achieving an hematologic improvement defined as: neutrophil improvement: increase from baseline >0.5 × 10^9/L (baseline = 1.0 × 10^9/L ), platelet improvement: increase from baseline ≥ 30 × 10^9/L (baseline = 100 × 10^9/L), hemoglobin improvement: Hb increase from baseline ≥ 1 g/dL (baseline<11 g/dL)

Number of patients who met criteria varied across parameters

Posted

Number

percentage of participants

Baseline up to 24 weeks

ID	Title	Description
OG000	Erythropoietin Alpha	Starting dose was erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement was inadequate, dose was escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement was inadequate, participants were switched to the combination arm. At any time when erythroid response was achieved, erythropoietin treatment was stopped until end of study.
OG001	Deferasirox + Erythropoietin Alpha	Starting dose was deferasirox dispersible tablet (DT) 10 mg/kg/day or deferasirox film-coated tablet FCT) 7 mg/kg/day in combination with erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement was inadequate, erythropoietin dose was escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement was inadequate, participants were discontinued from the study. At any time when erythroid response was achieved, erythropoietin treatment was stopped study and Deferasirox treatment was continued until end of study

Secondary

Absolute Change in Hemoglobin Values up to 24 Weeks

Absolute change in hemoglobin values for patients showing improvement: Hemoglobin improvement Hb increase from baseline ≥ 1 g/dL (baseline<11 g/dL)

Posted

Mean

Standard Deviation

g/dL

Baseline up to 24 weeks

ID	Title	Description
OG000	Erythropoietin Alpha	Starting dose was erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement was inadequate, dose was escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement was inadequate, participants were switched to the combination arm. At any time when erythroid response was achieved, erythropoietin treatment was stopped until end of study.
OG001	Deferasirox + Erythropoietin Alpha	Starting dose was deferasirox dispersible tablet (DT) 10 mg/kg/day or deferasirox film-coated tablet FCT) 7 mg/kg/day in combination with erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement was inadequate, erythropoietin dose was escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement was inadequate, participants were discontinued from the study. At any time when erythroid response was achieved, erythropoietin treatment was stopped study and Deferasirox treatment was continued until end of study

Secondary

Absolute Change in Platelets and Neutrophil Levels up to 24 Weeks

Absolute change in platelets and neutrophil levels for participants showing improvement: neutrophil improvement: increase from baseline >0.5 × 10^9/L (baseline = 1.0 × 10^9/L ), platelet improvement: increase from baseline ≥ 30 × 10^9/L (baseline = 100 × 10^9/L)

Number of patients who met criteria varied across parameters

Posted

Mean

Standard Deviation

10^9 cells/L

Baseline up to 24 weeks

ID	Title	Description
OG000	Erythropoietin Alpha	Starting dose was erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement was inadequate, dose was escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement was inadequate, participants were switched to the combination arm. At any time when erythroid response was achieved, erythropoietin treatment was stopped until end of study.
OG001	Deferasirox + Erythropoietin Alpha	Starting dose was deferasirox dispersible tablet (DT) 10 mg/kg/day or deferasirox film-coated tablet FCT) 7 mg/kg/day in combination with erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement was inadequate, erythropoietin dose was escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement was inadequate, participants were discontinued from the study. At any time when erythroid response was achieved, erythropoietin treatment was stopped study and Deferasirox treatment was continued until end of study

Secondary

Summary of Erythroid Response in Participants Randomized to EPO Alone at Baseline and Switched to EPO+DFX After 12 Weeks of Treatment (Full Analysis Set)

Erythroid response: hemoglobin increase from baseline > = 1.5 g/dL (baseline <11 g/dL)

Posted

Number

participants

Week 13 up to 24 weeks

ID	Title	Description
OG000	EPO+DFX (12 Weeks)	Patients randomized to EPO alone with inadequate response at 12 weeks who had been switched over to combination EPO+DFX

Units	Counts
Participants	OG0005

Secondary

Summary of Erythroid Response Within 24 Weeks in Participants Randomized to EPO at Baseline and Not Switched to EPO+DFX After 12 Weeks of Treatment (Full Analysis Set)

Erythroid response: hemoglobin increase from baseline > = 1.5 g/dL (baseline <11 g/dL). Percentages are based on N. Confidence intervals are calculated using Clopper-Pearson method. Hemoglobin value is at time of first response

Posted

Number

95% Confidence Interval

percentage of participants

baseline up to 24 weeks

ID	Title	Description
OG000	EPO (24 Weeks)	Patients who were in EPO alone group and were not switched to EPO+DFX after 12 weeks,

Units	Counts
Participants	OG000

Secondary

Absolute Change in Serum Ferritin up to 24 Weeks for Erythropoietin Alpha Arm (Full Analysis Set)

Absolute change in serum ferritin from baseline

Number of patients analyzed varied by visit

Posted

Median

Full Range

ng/mL

Baseline up to 24 weeks

ID	Title	Description
OG000	Erythropoietin Alpha	Starting dose was erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement was inadequate, dose was escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement was inadequate, participants were switched to the combination arm. At any time when erythroid response was achieved, erythropoietin treatment was stopped until end of study.

Units	Counts
Participants	OG000

Secondary

Absolute Change in Serum Ferritin up to 24 Weeks for Deferasirox + Erythropoietin Alpha Arm (Full Analysis Set)

Absolute change in serum ferritin from baseline

Number of patients analyzed varied by visit

Posted

Median

Full Range

ng/mL

Baseline up to 24 weeks

ID	Title	Description
OG000	Deferasirox + Erythropoietin Alpha	Starting dose was deferasirox dispersible tablet (DT) 10 mg/kg/day or deferasirox film-coated tablet FCT) 7 mg/kg/day in combination with erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement was inadequate, erythropoietin dose was escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement was inadequate, participants were discontinued from the study. At any time when erythroid response was achieved, erythropoietin treatment was stopped study and Deferasirox treatment was continued until end of study

Units	Counts
Participants	OG000

Secondary

Absolute Change in Serum Ferritin up to 24 Weeks for EPO+DFX at 12 Weeks Arm (Full Analysis Set)

Absolute change in serum ferritin from baseline

Number of patients analyzed varied by visit

Posted

Median

Full Range

ng/mL

Baseline up 24 weeks

ID	Title	Description
OG000	EPO+DFX at 12	Patients randomized to EPO alone with inadequate response at 12 weeks who had been switched over to combination EPO+DFX

Units	Counts
Participants	OG0005

Secondary

Absolute Change in Hemoglobin (Hb) From Baseline for Erythropoietin Alpha Arm (Full Analysis Set)

Number of patients analyzed varied by visit

Posted

Median

Full Range

g/dL

Baseline up to 24 weeks

ID	Title	Description
OG000	Erythropoietin Alpha	Starting dose was erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement was inadequate, dose was escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement was inadequate, participants were switched to the combination arm. At any time when erythroid response was achieved, erythropoietin treatment was stopped until end of study.

Units	Counts
Participants	OG000

Secondary

Absolute Change in Hemoglobin (Hb) From Baseline for Deferasirox + Erythropoietin Alpha Arm (Full Analysis Set)

Number of patients analyzed varied by visit

Posted

Median

Full Range

g/dL

Baseline up to 24 weeks

ID	Title	Description
OG000	Deferasirox + Erythropoietin Alpha	Starting dose was deferasirox dispersible tablet (DT) 10 mg/kg/day or deferasirox film-coated tablet FCT) 7 mg/kg/day in combination with erythropoietin 40,000 units/week. If after 4 weeks erythroid improvement was inadequate, erythropoietin dose was escalated to 60,000 units/week. If after 12 weeks of treatment, erythroid improvement was inadequate, participants were discontinued from the study. At any time when erythroid response was achieved, erythropoietin treatment was stopped study and Deferasirox treatment was continued until end of study

Units	Counts
Participants	OG000

Secondary

Absolute Change in Hemoglobin (Hb) From Baseline for EPO+DFX at 12 Weeks Arm (Full Analysis Set)

This analysis included patients randomized either to EPO or DFX+EPO at baseline as well as patients who did not have erythroid response at week 12 in the EPO group and switched to combination therapy. The time-course of Hb and its absolute changes from baseline was summarized by descriptive statistics by visit and erythroid response. Patients randomized to EPO and not switching after 12 weeks to EPO+DFX would consist of only responders.

Number of patients analyzed varied by visit

Posted

Median

Full Range

g/dL

Baseline up to 24 weeks

ID	Title	Description
OG000	EPO+DFX at 12 Weeks	This analysis included patients randomized either to EPO or DFX+EPO at baseline as well as patients who did not have erythroid response at week 12 in the EPO group and switched to combination therapy. The time-course of Hb and its absolute changes from baseline was summarized by descriptive statistics by visit and erythroid response. Patients randomized to EPO and not switching after 12 weeks to EPO+DFX would consist of only responders

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	EPO A	Patients receiving EPO during the first 12 weeks and no switching to EPO+DFX arm	7	1	7	4	7
EG001	EPO+DFX DT	Patients receiving EPO+DFX from week 1 and continuing with EPO+DFX after 12 weeks or with DFX alone after 12 weeks	10	1	10	10	10
EG002	EPO+DFX FCT	Patients receiving EPO alone and switched to EPO+DFX after 12 weeks of treatment	1	1	1	1	1
EG003	Switched to DFX+EPO After 12 Weeks	Switched to DFX+EPO after 12 weeks	5	1	5	5	5

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Tachycardia	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG0031 affected5 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Pyrexia	General disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Diverticulitis	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0021 affected1 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0011 affected10 at risk EG0020 affected1 at risk EG003
C-reactive protein increased	Investigations	MedDRA (20.0)	Systematic Assessment	EG0001 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Syncope	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0021 affected1 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected7 at risk EG0012 affected10 at risk EG0020 affected1 at risk EG0031 affected5 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Anal fissure	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0011 affected10 at risk EG0020 affected1 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0013 affected10 at risk EG0021 affected1 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0011 affected10 at risk EG0020 affected1 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Asthenia	General disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0011 affected10 at risk EG0020 affected1 at risk EG003
Gravitational oedema	General disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0011 affected10 at risk EG0020 affected1 at risk EG003
Injection site bruising	General disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Oedema peripheral	General disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Pyrexia	General disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0011 affected10 at risk EG0020 affected1 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0011 affected10 at risk EG0020 affected1 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0011 affected10 at risk EG0020 affected1 at risk EG003
Herpes zoster	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Hordeolum	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0011 affected10 at risk EG0020 affected1 at risk EG003
Influenza	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Localised infection	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Lung infection	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Sinusitis	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0011 affected10 at risk EG0020 affected1 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Blood creatinine increased	Investigations	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0011 affected10 at risk EG0020 affected1 at risk EG003
Blood uric acid increased	Investigations	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0011 affected10 at risk EG0020 affected1 at risk EG003
Haemoglobin decreased	Investigations	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0011 affected10 at risk EG0020 affected1 at risk EG003
Heart rate increased	Investigations	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Weight decreased	Investigations	MedDRA (20.0)	Systematic Assessment	EG0001 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected7 at risk EG0011 affected10 at risk EG0020 affected1 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0011 affected10 at risk EG0020 affected1 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0011 affected10 at risk EG0020 affected1 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected7 at risk EG0011 affected10 at risk EG0020 affected1 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected7 at risk EG0010 affected10 at risk EG0020 affected1 at risk EG003

ID	Term
D009190	Myelodysplastic Syndromes
D000754	Anemia, Refractory, with Excess of Blasts
D006402	Hematologic Diseases
D000095542	Cytopenia

ID	Term
D000077588	Deferasirox
D000068817	Epoetin Alfa

Ancestor Terms

ID	Term
D001565	Benzoates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D004921	Erythropoietin
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates
D016298	Hematopoietic Cell Growth Factors
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011506	Proteins
D001685	Biological Factors

Title

Denominators

Categories

Title	Measurements
	OG0000

Title

Denominators

Categories

Responders - Week 5

- ParticipantsOG0001

Title	Measurements
	OG000-116(-116 to -116)

Responders - Week 9

- ParticipantsOG0001

Title	Measurements
	OG000-136(-136 to -136)

Responders - Week 13

- ParticipantsOG0001

Title	Measurements
	OG00059.5(59.5 to 59.5)

Responders - Week 17

- ParticipantsOG0001

Title	Measurements
	OG00074.5(74.5 to 74.5)

Non-responders - Week 5

- ParticipantsOG0004

Title	Measurements
	OG000-68.3(-144 to 221.3)

Non-responders - Week 9

- ParticipantsOG0003

Title	Measurements
	OG000-148(-319 to 321.3)

Non-responders - Week 13

- ParticipantsOG0004

Title	Measurements
	OG000220.4(-228 to 635.3)

Non-responders - Week 17

- ParticipantsOG0002

Title	Measurements
	OG000-16.6(-28.5 to -4.7)

Non-responders - Week 21

- ParticipantsOG0003

Title	Measurements
	OG000-10.5(-463 to 367.3)

ID	Term
D001855	Bone Marrow Diseases
D006425	Hemic and Lymphatic Diseases
D000753	Anemia, Refractory
D000740	Anemia