Study to Compare Ferric Carboxymaltose With Placebo in Pa... | NCT02937454

ID	Type	Description	Link
2016-001467-36	EudraCT Number

Name	Class
Worldwide Clinical Trials	OTHER
Cytel Inc.	INDUSTRY

Label	Type	Description	Intervention Names
ferric carboxymaltose	Active Comparator	The first dose of study treatment will be administered for all randomised subjects while the patient is still hospitalised for the Index hospitalisation. The subsequent administrations of study treatment will be done as part of the outpatient clinic visits.	Drug: ferric carboxymaltose
normal saline 0.9%	Placebo Comparator	The first dose of study treatment will be administered for all randomised subjects on the same day as randomisation.	Other: Normal saline 0.9%

Name	Type	Description	Arm Group Labels	Other Names
ferric carboxymaltose	Drug	FCM will be administered as an undiluted bolus injection. The study treatment dose (mL) to be administered will be determined by the patient's body weight and haemoglobin (Hb) value at the respective visits where study treatment will be administered

Measure	Description	Time Frame
HF Hospitalizations and CV Death	HF = Heart Failure, CV = Cardiovascular. The composite of recurrent HF hospitalizations and CV death up to 52 weeks after randomization Total hospitalisations included first and recurrent events. If a participant was hospitalised for heart failure and died within 24 h from any cardiovascular event, this was counted as one event.	up to 52 weeks after randomization

Measure	Description	Time Frame
Recurrent CV Hospitalisations and CV Death	CV = Cardiovascular The composite of recurrent CV hospitalisations and CV death at 52 weeks after randomisation Total hospitalisations included first and recurrent events. If a participant was hospitalised for a cardiovascular reason and died within 24 h of admission from any cardiovascular event, this was counted as one event.	up to 52 weeks after randomization

Measure	Description	Time Frame
HF Hospitalisations	HF = Heart Failure Number of participants with at least one HF Hospitalisation up to 52 weeks after randomisation	up to 52 weeks after randomisation
CV Hospitalisations	CV = Cardiovascular Number of participants with at least one CV Hospitalisation up to 52 weeks after randomisation

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Currently hospitalised for an episode of acute heart failure (AHF) where AHF was the primary reason for hospitalisation. All of the following (i.e., items a to d) must apply:
1. Upon admission for the AHF episode, persistent dyspnoea at rest in a recumbent sitting position (30-45°) or with minimal exertion
2. Upon or during the AHF admission, at least 2 of the following clinical findings were present: i. Congestion on chest X-ray ii. Rales on chest auscultation iii. Oedema ≥1+ on a 0-3+ scale, indicating indentation of skin with mild digital pressure that requires 10 or more seconds to resolve in any dependent area including extremities or sacral region iv. Elevated jugular venous pressure (≥8 cm H2O)
3. Natriuretic peptide levels, measured ≤72 hours of the AHF admission must have been: i. Brain natriuretic peptide (BNP) ≥400 pg/mL or N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,600 pg/mL or ii. BNP ≥600 pg/mL or NT-proBNP ≥2,400 pg/mL for subjects presenting with atrial fibrillation when the blood sample was taken iii. For subjects treated with an angiotensin receptor neprilysin inhibitor (ARNI) in the previous 4 weeks prior to randomisation only NT-proBNP values should be considered
4. AHF episode treated with minimally 40 mg of IV furosemide (or equivalent IV loop diuretic defined as 20 mg of torasemide or 1 mg of bumetanide)
Subject is iron deficient defined as serum ferritin <100 ng/mL or 100 ng/mL ≤ serum ferritin ≤299 ng/mL if TSAT <20%.
Left ventricular ejection fraction <50% (assessed and documented within 12 months prior to randomisation).
Male or female aged ≥18 years old.
Subject (or legally acceptable representative)* has provided the appropriate written informed consent. Subject must provide written informed consent before any study-specific procedures are performed.

Exclusion Criteria:

Dyspnoea due to non-cardiac causes such as acute or chronic respiratory disorders or infections (i.e., severe chronic obstructive pulmonary disease, acute bronchitis, pneumonia, primary pulmonary hypertension).
Temperature >38°C (oral or equivalent), active infective endocarditis, sepsis, systemic inflammatory response syndrome, or any other active infection requiring anti-microbial treatment at any time during an Index hospitalisation. (Note that it does NOT include short-term prophylactic administration of antibiotics or short-term temperature elevation at admission which is no longer present at the time point of discharge/randomisation).
Documented restricted amyloid myocardiopathy, or acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy. (Note that it does NOT include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function).
Clinical evidence of acute coronary syndrome, transient ischemic attack or stroke, within the last 30 days prior randomisation.
Severe valvular or left ventricular outflow obstruction disease needing intervention.
Coronary-artery bypass graft, cardiac resynchronisation therapy device implantation, percutaneous intervention (e.g., cardiac, cerebrovascular, aortic, diagnostic catheters are allowed) or major surgery that led to significant blood loss, including thoracic and cardiac surgery, within the last 3 months prior to randomisation.
Subject has a body weight <35 kg at randomisation.
Subject at an immediate need of transfusion or with a Hb <8 g/dL* or with a Hb >15 g/dL.
Subjects on treatment for Vitamin B12 and/or serum folate deficiency. Note: Use of Vitamin B12 and folic acid as supplement therapy (not for deficiency treatment) is permitted.
Subject with a known anaemia not attributed to ID (e.g., other microcytic anaemia) or with an evidence of iron overload (e.g., haemochromatosis) or disturbances in the utilisation of iron.
Subject has known hypersensitivity to any of the study products to be administered or known serious hypersensitivity to other parenteral iron products.
Subject with known severe allergies including drug allergies, history of severe asthma, eczema or other atopic allergy and in subjects with immune or inflammatory conditions (e.g., systemic lupus erythematosus, rheumatoid arthritis).
History of erythropoietin stimulating agent, IV iron therapy, and/or blood transfusion in previous 3 months prior to randomisation.
Oral iron therapy at doses >100 mg/day in previous 4 weeks prior to randomisation. Note: Ongoing use of multivitamins containing iron <75 mg/day are permitted.
Currently receiving systemic chemotherapy and/or radiotherapy.
Renal dialysis (previous, current or planned within the next 6 months).
Subject has known active malignancy of any organ system, i.e., clinical evidence of current malignancy or not in stable remission for at least 3 years since completion of last treatment with exception of non-invasive basal cell carcinoma, squamous cell carcinoma of the skin or cervical intra-epithelial neoplasia.
Terminal illness other than HF with expected survival <12 months.
Chronic liver disease (including active hepatitis) and/or alanine transaminase or aspartate transaminase above 3 times the upper limit of the normal range.
Subjects with known hepatitis B surface antigen positivity and/or hepatitis C virus ribonucleic acid positivity.
Subject previously randomised into this study. Note: Subjects may be rescreened but when rescreened, all tests must fall inside the maximum specified screening windows for each criterion.
Subject is currently enrolled in or has completed any other investigational device or drug study <30 days prior to screening, or is receiving other investigational agent(s).
Subject is pregnant (e.g., positive human chorionic gonadotropin test) or breast feeding.
If of childbearing potential, subject is not using adequate contraceptive precautions. Subject must agree to use adequate contraception during the study and for 1 month after the last dose of study treatment. A highly effective method of birth control must be used.
Subject has a history of drug or alcohol abuse within 2 years prior to screening.
Subject has a significant medical condition(s), anticipated need for major surgery during the study, or any other kind of disorder that may be associated with increased risk to the subject, or may interfere with study assessments, outcomes, or the ability to provide written informed consent or comply with study procedures, in the Investigator's opinion.
- Following section in italics is applicable for The Netherlands, Spain and Singapore only (NL, ES and SG only): 'The lower threshold of Hb values is set to 10 g/dL.'

Name	Affiliation	Role
Piotr Ponikowski, MD	Medical University Clinical Military Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario Austral		Buenos Aires		1500	Argentina
InCor -Instituto do Coração HCFMUSP

PubMed Identifier	Type	Citation	Retractions
37592272	Derived	Rosano G, Ponikowski P, Vitale C, Anker SD, Butler J, Fabien V, Filippatos G, Kirwan BA, Macdougall IC, Metra M, Ruschitzka F, Kumpeson V, Goehring UM, van der Meer P, Jankowska EA; AFFIRM-AHF investigators. Intravenous ferric carboxymaltose for iron repletion following acute heart failure in patients with and without diabetes: a subgroup analysis of the randomized AFFIRM-AHF trial. Cardiovasc Diabetol. 2023 Aug 17;22(1):215. doi: 10.1186/s12933-023-01943-z.
37382961

ID	Title	Description
FG000	FCM (Ferric Carboxymaltose)	Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level. From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 1, 2020	Apr 22, 2021

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

HF Hospitalizations and CV Death

HF = Heart Failure, CV = Cardiovascular.

The composite of recurrent HF hospitalizations and CV death up to 52 weeks after randomization

Total hospitalisations included first and recurrent events. If a participant was hospitalised for heart failure and died within 24 h from any cardiovascular event, this was counted as one event.

Full Analysis Set (FAS): All randomised participants for whom administration of study treatment was started and who had at least one post-baseline visit (including calls), death or hospitalisation or who withdrew from the study after but not on the randomisation date.

The management and follow-up of patients was affected by the COVID-19 pandemic. Participants were censored in each country on the date when the first patient with COVID-19 was reported in the respective country.

Posted

Number

Events

up to 52 weeks after randomization

ID	Title	Description
OG000	FCM (Ferric Carboxymaltose)	Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level. From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates.
OG001	Placebo (Normal Saline (NaCl 0.9%))	Normal saline (NaCl 0.9%), administered by bolus intravenous (IV) injection at a volume corresponding to the FCM dose determined by the participant's body weight and haemoglobin (Hb) level (i.e., 10 ml or 20 ml per administration). From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the participant's Hb levels measured prior to planned dosing dates.

Units	Counts
Participants	OG000558 OG001550

Title

Denominators

Categories

Full Analysis Set (FAS)

Title	Measurements
	OG000293 OG001372

Covid-19 Sensitivity Analysis

Title	Measurements
	OG000

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	Full Analysis Set (FAS)	Negative binomial model	Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.	0.059		Annualised event rate ratio (RR)	0.79			2-Sided	95	0.62	1.01					Other
OG000 OG001

Secondary

Recurrent CV Hospitalisations and CV Death

CV = Cardiovascular

The composite of recurrent CV hospitalisations and CV death at 52 weeks after randomisation

Total hospitalisations included first and recurrent events. If a participant was hospitalised for a cardiovascular reason and died within 24 h of admission from any cardiovascular event, this was counted as one event.

Posted

Number

Events

up to 52 weeks after randomization

ID	Title	Description
OG000	FCM (Ferric Carboxymaltose)	Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level. From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates.
OG001	Placebo (Normal Saline (NaCl 0.9%))

Secondary

HF Hospitalisations

HF = Heart Failure

HF hospitalisations up to 52 weeks after randomisation analysed as recurrent event.

Posted

Number

Events

up to 52 weeks after randomisation

ID	Title	Description
OG000	FCM (Ferric Carboxymaltose)	Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level. From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates.
OG001	Placebo (Normal Saline (NaCl 0.9%))	Normal saline (NaCl 0.9%), administered by bolus intravenous (IV) injection at a volume corresponding to the FCM dose determined by the participant's body weight and haemoglobin (Hb) level (i.e., 10 ml or 20 ml per administration). From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the participant's Hb levels measured prior to planned dosing dates.

Secondary

CV Mortality

CV = Cardiovascular

CV mortality analysed as time to first event at 52 weeks after randomisation.

Posted

Count of Participants

Participants

at 52 weeks after randomisation.

ID	Title	Description
OG000	FCM (Ferric Carboxymaltose)	Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level. From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates.
OG001	Placebo (Normal Saline (NaCl 0.9%))	Normal saline (NaCl 0.9%), administered by bolus intravenous (IV) injection at a volume corresponding to the FCM dose determined by the participant's body weight and haemoglobin (Hb) level (i.e., 10 ml or 20 ml per administration). From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the participant's Hb levels measured prior to planned dosing dates.

Secondary

Composite of HF Hospitalisations or CV Death

HF = Heart Failure, CV = Cardiovascular

Analysed as time to first event at 52 weeks after randomisation. The number of participants with at least one HF Hospitalisation or CV Death is presented below.

Posted

Count of Participants

Participants

at 52 weeks after randomisation

ID	Title	Description
OG000	FCM (Ferric Carboxymaltose)	Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level. From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates.
OG001	Placebo (Normal Saline (NaCl 0.9%))	Normal saline (NaCl 0.9%), administered by bolus intravenous (IV) injection at a volume corresponding to the FCM dose determined by the participant's body weight and haemoglobin (Hb) level (i.e., 10 ml or 20 ml per administration). From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the participant's Hb levels measured prior to planned dosing dates.

Secondary

Days Lost Due to HF Hospitalisation or CV Death

HF = Heart Failure, CV = Cardiovascular

Number of days lost due to heart failure hospitalisations or cardiovascular death corresponds to the total number of days in hospital for heart failure from randomisation to last known date. Days lost due to cardiovascular death are added to the number of days lost due to heart failure hospitalisation.

Posted

Mean

Standard Deviation

days

at 52 weeks after randomisation

ID	Title	Description
OG000	FCM (Ferric Carboxymaltose)	Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level. From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates.
OG001	Placebo (Normal Saline (NaCl 0.9%))

Other Pre-specified

HF Hospitalisations

HF = Heart Failure

Number of participants with at least one HF Hospitalisation up to 52 weeks after randomisation

Posted

Count of Participants

Participants

up to 52 weeks after randomisation

ID	Title	Description
OG000	FCM (Ferric Carboxymaltose)	Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level. From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates.
OG001	Placebo (Normal Saline (NaCl 0.9%))	Normal saline (NaCl 0.9%), administered by bolus intravenous (IV) injection at a volume corresponding to the FCM dose determined by the participant's body weight and haemoglobin (Hb) level (i.e., 10 ml or 20 ml per administration). From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the participant's Hb levels measured prior to planned dosing dates.

Other Pre-specified

CV Hospitalisations

CV = Cardiovascular

Number of participants with at least one CV Hospitalisation up to 52 weeks after randomisation

Posted

Count of Participants

Participants

up to 52 weeks after randomisation

ID	Title	Description
OG000	FCM (Ferric Carboxymaltose)	Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level. From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates.
OG001	Placebo (Normal Saline (NaCl 0.9%))	Normal saline (NaCl 0.9%), administered by bolus intravenous (IV) injection at a volume corresponding to the FCM dose determined by the participant's body weight and haemoglobin (Hb) level (i.e., 10 ml or 20 ml per administration). From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the participant's Hb levels measured prior to planned dosing dates.

Other Pre-specified

All-cause Mortality

Number of participants who died up to 52 weeks after randomisation

Posted

Count of Participants

Participants

up to 52 weeks after randomisation

ID	Title	Description
OG000	FCM (Ferric Carboxymaltose)	Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level. From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates
OG001	Placebo (Normal Saline (NaCl 0.9%))	Normal saline (NaCl 0.9%), administered by bolus intravenous (IV) injection at a volume corresponding to the FCM dose determined by the participant's body weight and haemoglobin (Hb) level (i.e., 10 ml or 20 ml per administration). From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the participant's Hb levels measured prior to planned dosing dates.

Other Pre-specified

Change From Baseline in NYHA Functional Class

NYHA = New York Heart Association

NYHA functional class was assessed as Class I, II, III, IV or V:

Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.

Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.

Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m). Comfortable only at rest.

Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. If a participant was hospitalised at any point during any post-baseline visit and did not have any NYHA assessment for this visit, then Class IV was to be imputed for the visit.

Class V - Imputed for participants who died.

Lower response categories are better for score NYHA.

Posted

Count of Participants

Participants

at 6, 12, 24 and 52 weeks after randomisation

ID	Title	Description
OG000	FCM (Ferric Carboxymaltose)	Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level. From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates

Other Pre-specified

Change From Baseline in the EQ-5D-5L Questionnaire Indexed Value

EQ-5D-5L: European Quality of Life-5 Dimensions-5 Levels

The EQ 5D questionnaire consists of a health descriptive system for participants to self-classify and rate their health status on the day of administration.

The descriptive system includes 5 items/dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, which are coded from 1 (best state) to 5 (worst state).

Posted

Mean

Standard Error

Change from baseline in EQ-5D-5L

at 6, 24 and 52 weeks after randomisation

ID	Title	Description
OG000	FCM (Ferric Carboxymaltose)	Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level. From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates.
OG001	Placebo (Normal Saline (NaCl 0.9%))	Normal saline (NaCl 0.9%), administered by bolus intravenous (IV) injection at a volume corresponding to the FCM dose determined by the participant's body weight and haemoglobin (Hb) level (i.e., 10 ml or 20 ml per administration). From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the participant's Hb levels measured prior to planned dosing dates.

Other Pre-specified

KCCQ-12 Repeated-Measures Model for Analysis of Treatment Difference

KCCQ = Kansas City Cardiomyopathy Questionnaire

The KCCQ 12 is a health-related quality of life questionnaire for Heart Failure. It is a 12 item questionnaire that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge and Quality of life. Scores are generated for each domain and scaled from 0 to 100, with 0 denoting the lowest reportable health status and 100 the highest reportable health status.

Posted

Mean

Standard Error

KCCQ-12 score

up to 52 weeks after randomisation

ID	Title	Description
OG000	FCM (Ferric Carboxymaltose)	Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level. From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates.
OG001	Placebo (Normal Saline (NaCl 0.9%))

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac failure	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG000163 events116 affected559 at risk EG001215 events127 affected551 at risk
Cardiac failure acute	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG00025 events21 affected559 at risk EG00123 events17 affected551 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG00032 events20 affected559 at risk EG00135 events23 affected551 at risk
Atrial fibrillation	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG00011 events10 affected559 at risk EG0014 events4 affected551 at risk
Cardiac arrest	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0008 events8 affected559 at risk EG00112 events11 affected551 at risk
Angina unstable	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0005 events5 affected559 at risk EG0016 events5 affected551 at risk
Myocardial infarction	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0005 events5 affected559 at risk EG0012 events1 affected551 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0006 events5 affected559 at risk EG0011 events1 affected551 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0004 events4 affected559 at risk EG0017 events7 affected551 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0006 events4 affected559 at risk EG0013 events3 affected551 at risk
Angina pectoris	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0003 events3 affected559 at risk EG0011 events1 affected551 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0002 events2 affected559 at risk EG0018 events8 affected551 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0002 events2 affected559 at risk EG0010 events0 affected551 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0002 events2 affected559 at risk EG0013 events3 affected551 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0002 events2 affected559 at risk EG0013 events3 affected551 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0011 events1 affected551 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0011 events1 affected551 at risk
Bradycardia	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0012 events2 affected551 at risk
Cardiogenic shock	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0013 events3 affected551 at risk
Cardiomyopathy	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0011 events1 affected551 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0012 events1 affected551 at risk
Coronary artery disease	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0011 events1 affected551 at risk
Left ventricular failure	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0016 events5 affected551 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0014 events4 affected551 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Aortic valve disease mixed	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Atrial flutter	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0013 events3 affected551 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Cardiac amyloidosis	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Cardiorenal syndrome	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0012 events2 affected551 at risk
Nodal arrhythmia	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Pericarditis	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Sinus bradycardia	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Tachycardia	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Ventricular dyssynchrony	Cardiac disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Pneumonia	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG00011 events11 affected559 at risk EG00116 events15 affected551 at risk
Sepsis	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0007 events7 affected559 at risk EG0019 events9 affected551 at risk
Bronchitis	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0005 events5 affected559 at risk EG0012 events2 affected551 at risk
Cellulitis	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0005 events4 affected559 at risk EG0013 events3 affected551 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0004 events4 affected559 at risk EG0015 events5 affected551 at risk
Septic shock	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0003 events3 affected559 at risk EG0013 events3 affected551 at risk
Bacteraemia	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0002 events2 affected559 at risk EG0011 events1 affected551 at risk
Erysipelas	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0002 events2 affected559 at risk EG0010 events0 affected551 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0002 events2 affected559 at risk EG0011 events1 affected551 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0002 events2 affected559 at risk EG0011 events1 affected551 at risk
Pyelonephritis acute	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0002 events2 affected559 at risk EG0010 events0 affected551 at risk
Dengue fever	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Skin infection	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Staphylococcal infection	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Suspected COVID-19	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0011 events1 affected551 at risk
Urosepsis	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0011 events1 affected551 at risk
Abdominal abscess	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Arthritis bacterial	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Carbuncle	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Diverticulitis	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Gangrene	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Infected skin ulcer	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Influenza	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Intervertebral discitis	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Pneumonia bacterial	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0012 events2 affected551 at risk
Postoperative wound infection	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Respiratory tract infection	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0012 events2 affected551 at risk
Shewanella algae bacteraemia	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Tracheobronchitis	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Viral infection	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0013 events2 affected551 at risk
Wound infection	Infections and infestations	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Death	General disorders	MedDRA Version 23.0	Systematic Assessment	EG0008 events8 affected559 at risk EG00113 events13 affected551 at risk
Sudden cardiac death	General disorders	MedDRA Version 23.0	Systematic Assessment	EG0005 events5 affected559 at risk EG0015 events5 affected551 at risk
Sudden death	General disorders	MedDRA Version 23.0	Systematic Assessment	EG0005 events5 affected559 at risk EG0017 events7 affected551 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA Version 23.0	Systematic Assessment	EG0004 events3 affected559 at risk EG0012 events2 affected551 at risk
Chest pain	General disorders	MedDRA Version 23.0	Systematic Assessment	EG0002 events2 affected559 at risk EG0010 events0 affected551 at risk
Oedema peripheral	General disorders	MedDRA Version 23.0	Systematic Assessment	EG0002 events2 affected559 at risk EG0012 events2 affected551 at risk
Pyrexia	General disorders	MedDRA Version 23.0	Systematic Assessment	EG0002 events2 affected559 at risk EG0010 events0 affected551 at risk
Chest discomfort	General disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0011 events1 affected551 at risk
Malaise	General disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0011 events1 affected551 at risk
Non-cardiac chest pain	General disorders	MedDRA Version 23.0	Systematic Assessment	EG0003 events1 affected559 at risk EG0016 events4 affected551 at risk
Asthenia	General disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Generalised oedema	General disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Influenza like illness	General disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA Version 23.0	Systematic Assessment	EG0007 events7 affected559 at risk EG0013 events3 affected551 at risk
Epilepsy	Nervous system disorders	MedDRA Version 23.0	Systematic Assessment	EG0004 events3 affected559 at risk EG0010 events0 affected551 at risk
Syncope	Nervous system disorders	MedDRA Version 23.0	Systematic Assessment	EG0003 events3 affected559 at risk EG0014 events4 affected551 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA Version 23.0	Systematic Assessment	EG0002 events2 affected559 at risk EG0010 events0 affected551 at risk
Altered state of consciousness	Nervous system disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0011 events1 affected551 at risk
Cerebrovascular insufficiency	Nervous system disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0011 events1 affected551 at risk
Headache	Nervous system disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Ischaemic stroke	Nervous system disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0014 events4 affected551 at risk
Presyncope	Nervous system disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Coma	Nervous system disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Thrombotic cerebral infarction	Nervous system disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0005 events4 affected559 at risk EG0016 events6 affected551 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0004 events4 affected559 at risk EG0015 events5 affected551 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0003 events3 affected559 at risk EG0012 events2 affected551 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0003 events2 affected559 at risk EG0014 events3 affected551 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0002 events2 affected559 at risk EG0011 events1 affected551 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0013 events3 affected551 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Dyspnoea at rest	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0018 events8 affected551 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0011 events1 affected551 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Choking	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Orthopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA Version 23.0	Systematic Assessment	EG0008 events8 affected559 at risk EG0016 events6 affected551 at risk
Renal failure	Renal and urinary disorders	MedDRA Version 23.0	Systematic Assessment	EG0005 events5 affected559 at risk EG0015 events5 affected551 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA Version 23.0	Systematic Assessment	EG0002 events2 affected559 at risk EG0012 events2 affected551 at risk
Renal impairment	Renal and urinary disorders	MedDRA Version 23.0	Systematic Assessment	EG0002 events2 affected559 at risk EG0010 events0 affected551 at risk
End stage renal disease	Renal and urinary disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Haematuria	Renal and urinary disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Urinary retention	Renal and urinary disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Urinary tract inflammation	Renal and urinary disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Systematic Assessment	EG0002 events2 affected559 at risk EG0010 events0 affected551 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Systematic Assessment	EG0002 events2 affected559 at risk EG0011 events1 affected551 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 23.0	Systematic Assessment	EG0002 events2 affected559 at risk EG0010 events0 affected551 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA Version 23.0	Systematic Assessment	EG0002 events2 affected559 at risk EG0011 events1 affected551 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Fall	Injury, poisoning and procedural complications	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0011 events1 affected551 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0011 events1 affected551 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA Version 23.0	Systematic Assessment	EG0002 events1 affected559 at risk EG0010 events0 affected551 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Pharyngeal injury	Injury, poisoning and procedural complications	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Postoperative thoracic procedure complication	Injury, poisoning and procedural complications	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Traumatic haemothorax	Injury, poisoning and procedural complications	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA Version 23.0	Systematic Assessment	EG0003 events3 affected559 at risk EG0013 events3 affected551 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA Version 23.0	Systematic Assessment	EG0002 events2 affected559 at risk EG0011 events1 affected551 at risk
Aortic dissection	Vascular disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Circulatory collapse	Vascular disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Diabetic vascular disorder	Vascular disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Hypertension	Vascular disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Hypertensive crisis	Vascular disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Hypotension	Vascular disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0012 events2 affected551 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0011 events1 affected551 at risk
Peripheral ischaemia	Vascular disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0011 events1 affected551 at risk
Shock	Vascular disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Varicose ulceration	Vascular disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Deep vein thrombosis	Vascular disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0012 events2 affected551 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0002 events2 affected559 at risk EG0011 events1 affected551 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0002 events2 affected559 at risk EG0010 events0 affected551 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0002 events1 affected559 at risk EG0011 events1 affected551 at risk
Gastritis	Gastrointestinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Ileus	Gastrointestinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0003 events1 affected559 at risk EG0010 events0 affected551 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0011 events1 affected551 at risk
Large intestinal ulcer	Gastrointestinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Presbyoesophagus	Gastrointestinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0011 events1 affected551 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0013 events3 affected551 at risk
Ascites	Gastrointestinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0013 events1 affected551 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Gastric disorder	Gastrointestinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Intestinal infarction	Gastrointestinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Melaena	Gastrointestinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Gout	Metabolism and nutrition disorders	MedDRA Version 23.0	Systematic Assessment	EG0007 events3 affected559 at risk EG0010 events0 affected551 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 23.0	Systematic Assessment	EG0002 events2 affected559 at risk EG0012 events2 affected551 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Systematic Assessment	EG0002 events2 affected559 at risk EG0011 events1 affected551 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0013 events2 affected551 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0011 events1 affected551 at risk
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0012 events2 affected551 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0012 events2 affected551 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0012 events2 affected551 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Systematic Assessment	EG0003 events3 affected559 at risk EG0010 events0 affected551 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Systematic Assessment	EG0002 events1 affected559 at risk EG0011 events1 affected551 at risk
Hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0011 events1 affected551 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0011 events1 affected551 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0011 events1 affected551 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0012 events1 affected551 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Fracture nonunion	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Sarcopenia	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA Version 23.0	Systematic Assessment	EG0005 events4 affected559 at risk EG0014 events4 affected551 at risk
Lymphadenopathy mediastinal	Blood and lymphatic system disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0012 events1 affected551 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0011 events1 affected551 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Cholangitis	Hepatobiliary disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Jaundice	Hepatobiliary disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0012 events2 affected551 at risk
Diabetic foot	Endocrine disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Hyperthyroidism	Endocrine disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Corneal decompensation	Eye disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Ulcerative keratitis	Eye disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Device malfunction	Product Issues	MedDRA Version 23.0	Systematic Assessment	EG0002 events2 affected559 at risk EG0014 events4 affected551 at risk
Anxiety	Psychiatric disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Delirium	Psychiatric disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0011 events1 affected551 at risk
Depression	Psychiatric disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Disorientation	Psychiatric disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Heart transplant rejection	Immune system disorders	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Heart rate abnormal	Investigations	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Ejection fraction decreased	Investigations	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
International normalised ratio decreased	Investigations	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Abortion incomplete	Pregnancy, puerperium and perinatal conditions	MedDRA Version 23.0	Systematic Assessment	EG0001 events1 affected559 at risk EG0010 events0 affected551 at risk
Deafness unilateral	Ear and labyrinth disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Systematic Assessment	EG0000 events0 affected559 at risk EG0011 events1 affected551 at risk

ID	Term
D019189	Iron Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

ID	Title	Description
BG000	FCM (Ferric Carboxymaltose)	Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level. From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates.
BG001	Placebo (Normal Saline (NaCl 0.9%))	Normal saline (NaCl 0.9%), administered by bolus intravenous (IV) injection at a volume corresponding to the FCM dose determined by the participant's body weight and haemoglobin (Hb) level (i.e., 10 ml or 20 ml per administration). From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the participant's Hb levels measured prior to planned dosing dates.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Group 1 - FCM (Ferric Carboxymaltose)	Ferric carboxymaltose (FCM), administered by bolus IV injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the subject's body weight and Hb level. From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the subject's Hb levels measured prior to planned dosing dates.	99	559	250	559	51	559
EG001	Group 2 - Placebo (Normal Saline (NaCl 0.9%))	Normal saline (NaCl 0.9%), administered by bolus IV injection at a volume corresponding to the FCM dose determined by the subject's body weight and Hb level (i.e., 10 ml or 20 ml per administration).	96	551	282	551	45	551