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Mineral

Iron

Iron isomaltoside 1000

Trace Elements

Iron Supplement

Iron isomaltoside intravenously as bolus or infusion

intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose

iron isomaltoside 1000

oral, 200 mg per day (100 mg bid),12 weeks

iron sulphate

Lars Lykke Thomsen, MD

The purpose of this study is to compare the efficacy and safety of intravenous iron therapy with oral iron therapy in patients with cancer and chemotherapy induced anaemia.

A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)

A Phase III, Randomized, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)

Pharmacosmos A/S

The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.

Iron isomaltoside intravenously as bolus or infusion

iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose

Iron Isomaltoside 1000

oral iron sulphate twice a day

iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks

Iron Sulphate

Total

Age, Categorical

Sex: Female, Male

India

Germany

Denmark

Spain

Poland

Russian Federation

Sweden

United States

Region of Enrollment

Vice President Research & Development Department

The FAS population included all the subjects who were randomised into the study, received at least one dose of the study drug, and had at least one post-baseline Hb assessment. The subjects were considered as randomised, regardless of which treatment they actually received.

Change in Hb Concentration

Change in Hemoglobin From Baseline to Week 24

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)	NCT01145638	Non-myeloid Mal... Chemotherapy In...	iron isomaltosi... iron sulphate	18 Years -	Pharmacosmos A/S
A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)	NCT01145638	Non-myeloid Mal... Chemotherapy In...	iron isomaltosi... iron sulphate	18 Years -	Pharmacosmos A/S

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