Trial Outcomes & Findings for 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) (NCT NCT01145638)

NCT ID: NCT01145638

Last Updated: 2015-12-03

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 350 participants
• Primary outcome timeframe: Baseline week 4
• Results posted on: 2015-12-03

Participant Flow

Participant milestones

Measure	Iron Isomaltoside 1000 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 Sulphate oral iron sulphate twice a day iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks
Overall Study STARTED	231	119
Overall Study COMPLETED	141	62
Overall Study NOT COMPLETED	90	57

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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)

Baseline characteristics by cohort

Measure	Iron Isomaltoside 1000 n=231 Participants 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 Sulphate n=119 Participants oral iron sulphate twice a day iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks	Total n=350 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	187 Participants n=5 Participants	101 Participants n=7 Participants	288 Participants n=5 Participants
Age, Categorical >=65 years	44 Participants n=5 Participants	18 Participants n=7 Participants	62 Participants n=5 Participants
Sex: Female, Male Female	151 Participants n=5 Participants	90 Participants n=7 Participants	241 Participants n=5 Participants
Sex: Female, Male Male	80 Participants n=5 Participants	29 Participants n=7 Participants	109 Participants n=5 Participants
Region of Enrollment India	133 participants n=5 Participants	72 participants n=7 Participants	205 participants n=5 Participants
Region of Enrollment Germany	7 participants n=5 Participants	3 participants n=7 Participants	10 participants n=5 Participants
Region of Enrollment Denmark	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Spain	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Poland	40 participants n=5 Participants	16 participants n=7 Participants	56 participants n=5 Participants
Region of Enrollment Russian Federation	29 participants n=5 Participants	18 participants n=7 Participants	47 participants n=5 Participants
Region of Enrollment Sweden	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	6 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline week 4

Population: 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.

Outcome measures

Measure	Iron Isomaltoside 1000 n=192 Participants 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 Sulphate n=99 Participants oral iron sulphate twice a day iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks
Change in Hb Concentration	0.48 g/dL Interval -4.0 to 4.0	0.44 g/dL Interval -2.0 to 4.0

SECONDARY outcome

Timeframe: 24 weeks

Population: 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.

Outcome measures

Measure	Iron Isomaltoside 1000 n=157 Participants 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 Sulphate n=72 Participants oral iron sulphate twice a day iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks
Change in Hemoglobin From Baseline to Week 24	1.60 g/dL Interval -6.3 to 6.5	1.78 g/dL Interval -5.3 to 7.4

Adverse Events

Iron Isomaltoside 1000

Serious events: 32 serious events

Other events: 173 other events

Deaths: 0 deaths

Iron Sulphate

Serious events: 18 serious events

Other events: 107 other events

Deaths: 0 deaths

Serious adverse events

Measure	Iron Isomaltoside 1000 n=229 participants at risk 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 Sulphate n=112 participants at risk oral iron sulphate twice a day iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks
Blood and lymphatic system disorders Anaemia	0.87% 2/229 • Number of events 2 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.	1.8% 2/112 • Number of events 2 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.
Blood and lymphatic system disorders Neutropenia	0.87% 2/229 • Number of events 2 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.	0.00% 0/112 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.
Blood and lymphatic system disorders Pancytopenia	0.44% 1/229 • Number of events 1 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.	0.89% 1/112 • Number of events 1 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.
Cardiac disorders Atrial fibrillation	1.3% 3/229 • Number of events 3 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.	0.89% 1/112 • Number of events 1 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.
Cardiac disorders Cardiac failure	0.44% 1/229 • Number of events 1 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.	0.89% 1/112 • Number of events 1 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.
Gastrointestinal disorders Abdominal pain	0.44% 1/229 • Number of events 1 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.	0.00% 0/112 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.
Gastrointestinal disorders Ascites	0.00% 0/229 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.	0.89% 1/112 • Number of events 1 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.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.44% 1/229 • Number of events 1 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.	0.00% 0/112 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.
Gastrointestinal disorders Gastrointestinal polyp haemorrhage	0.44% 1/229 • Number of events 1 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.	0.00% 0/112 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.
Gastrointestinal disorders Mouth haemorrhage	0.44% 1/229 • Number of events 1 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.	0.00% 0/112 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.
Gastrointestinal disorders Stomatitis	0.44% 1/229 • Number of events 1 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.	0.00% 0/112 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.
General disorders Asthenia	0.44% 1/229 • Number of events 1 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.	0.89% 1/112 • Number of events 1 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.
General disorders Sudden death	0.44% 1/229 • Number of events 1 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.	0.00% 0/112 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.
Immune system disorders Anaphylactic reaction	0.44% 1/229 • Number of events 1 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.	0.00% 0/112 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.
Infections and infestations Pneumonia	0.87% 2/229 • Number of events 2 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.	0.00% 0/112 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.
Infections and infestations Sepsis	0.00% 0/229 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.	0.89% 1/112 • Number of events 1 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.
Infections and infestations Unirary tract infection	0.00% 0/229 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.	0.89% 1/112 • Number of events 1 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.
Injury, poisoning and procedural complications Post procedural complication	0.44% 1/229 • Number of events 1 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.	0.00% 0/112 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.
Investigations Electrocardiogram abnormal	0.44% 1/229 • Number of events 1 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.	0.00% 0/112 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.
Investigations Haemoglobin decreased	0.44% 1/229 • Number of events 1 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.	0.00% 0/112 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.
Metabolism and nutrition disorders Dehydration	0.87% 2/229 • Number of events 2 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.	0.00% 0/112 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.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/229 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.	0.89% 1/112 • Number of events 1 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.
Metabolism and nutrition disorders Hypoglycaemia	0.44% 1/229 • Number of events 1 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.	0.00% 0/112 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.
Metabolism and nutrition disorders Hyponatraemia	0.87% 2/229 • Number of events 2 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.	0.00% 0/112 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.
Musculoskeletal and connective tissue disorders Fistula	0.44% 1/229 • Number of events 1 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.	0.00% 0/112 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	3.5% 8/229 • Number of events 9 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.	6.2% 7/112 • Number of events 7 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/229 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.	0.89% 1/112 • Number of events 1 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.44% 1/229 • Number of events 1 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.	0.00% 0/112 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.00% 0/229 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.	0.89% 1/112 • Number of events 2 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.
Nervous system disorders Convulsion	0.00% 0/229 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.	0.89% 1/112 • Number of events 1 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.
Nervous system disorders Headache	0.00% 0/229 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.	0.89% 1/112 • Number of events 1 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.
Nervous system disorders Transient ischaemic attack	0.44% 1/229 • Number of events 1 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.	0.00% 0/112 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.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.44% 1/229 • Number of events 1 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.	0.00% 0/112 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.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.44% 1/229 • Number of events 1 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.	0.00% 0/112 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.
Respiratory, thoracic and mediastinal disorders Dyspnoe	0.44% 1/229 • Number of events 1 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.	0.00% 0/112 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.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/229 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.	0.89% 1/112 • Number of events 1 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.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.44% 1/229 • Number of events 1 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.	0.00% 0/112 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.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/229 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.	0.89% 1/112 • Number of events 1 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.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/229 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.	0.89% 1/112 • Number of events 1 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.
Respiratory, thoracic and mediastinal disorders Stridor	0.44% 1/229 • Number of events 1 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.	0.00% 0/112 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.

Other adverse events

Measure	Iron Isomaltoside 1000 n=229 participants at risk 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 Sulphate n=112 participants at risk oral iron sulphate twice a day iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks
Blood and lymphatic system disorders Anaemia	8.7% 20/229 • Number of events 22 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.	10.7% 12/112 • Number of events 13 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.
Blood and lymphatic system disorders Leukopenia	5.2% 12/229 • Number of events 13 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.	8.9% 10/112 • Number of events 13 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.
Blood and lymphatic system disorders Neutropenia	6.6% 15/229 • Number of events 21 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.	5.4% 6/112 • Number of events 9 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.
Blood and lymphatic system disorders Thrombocytopenia	4.8% 11/229 • Number of events 13 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.	6.2% 7/112 • Number of events 11 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.
Gastrointestinal disorders Constipation	3.1% 7/229 • Number of events 8 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.	6.2% 7/112 • Number of events 7 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.
Gastrointestinal disorders Diarrhoea	3.5% 8/229 • Number of events 14 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.	8.9% 10/112 • Number of events 11 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.
Gastrointestinal disorders Faeces discoloured	0.44% 1/229 • Number of events 1 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.	8.0% 9/112 • Number of events 9 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.
Gastrointestinal disorders Nausea	6.1% 14/229 • Number of events 19 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.	7.1% 8/112 • Number of events 12 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.
Gastrointestinal disorders Stomatitis	6.1% 14/229 • Number of events 14 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.	4.5% 5/112 • Number of events 5 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.
Gastrointestinal disorders Vomiting	7.0% 16/229 • Number of events 24 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.	6.2% 7/112 • Number of events 8 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.
General disorders Asthenia	7.9% 18/229 • Number of events 20 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.	6.2% 7/112 • Number of events 9 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.
General disorders Pyrexia	5.2% 12/229 • Number of events 13 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.	3.6% 4/112 • Number of events 4 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.
Skin and subcutaneous tissue disorders Alopecia	7.4% 17/229 • Number of events 17 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.	8.0% 9/112 • Number of events 9 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.
Metabolism and nutrition disorders Decreased appetite	3.5% 8/229 • Number of events 8 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.	5.4% 6/112 • Number of events 6 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.

Additional Information

Vice President Research & Development Department

Pharmacosmos A/S

Phone: +45 59485959

Email: llt@pharmacosmos.com

Results disclosure agreements

• Principal investigator is a sponsor employee If Pharmacosmos or its agents has not prepared a draft for submission to a peer reviewed journal prior to 1 year following completion of the study report, the investigators have the right to publish the results. Such publications are to be submitted to Pharmacosmos for comment 30 days prior to submission for publication.
• Publication restrictions are in place

Restriction type: OTHER