Trial Outcomes & Findings for To Assess the Impact of Ferric Carboxymaltose Compared With Iron Sucrose in Chinese Subjects on Correcting Iron Deficiency Anaemia (NCT NCT03591406)

NCT ID: NCT03591406

Last Updated: 2021-06-10

Results Overview

Haemoglobin (Hb)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 371 participants
• Primary outcome timeframe: From baseline at any time up to Week 8
• Results posted on: 2021-06-10

Participant Flow

Subjects who provided signed and dated informed consent were screened within 7 days prior to initial treatment administration.

Participant milestones

Measure	Ferric Carboxymaltose (FCM) Participants treated with FCM given by IV injection or drip infusion Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection Strength: 10 mL vials containing 500 mg iron per vial Dosage: 500mg/week or 1000mg/week (based on subject Body Weight (BW) and Hb value at screening) Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline) Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15.	Iron Sucrose (IS) Participants treated with IS given by IV injection or drip infusion Dosage Form: Sterile solution for injection containing 2% w/v iron Strength: 5 mL ampoules containing 100 mg iron per ampoule Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit \[mg\] = BW \[kg\] x (target Hb- actual Hb) \[g/dL\] x 2.4 + 500 mg, up to 11 IS injections will be given Route of administration: IV injection or drip infusion Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose.
Overall Study STARTED	188	183
Overall Study COMPLETED	181	174
Overall Study NOT COMPLETED	7	9

Reasons for withdrawal

Measure	Ferric Carboxymaltose (FCM) Participants treated with FCM given by IV injection or drip infusion Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection Strength: 10 mL vials containing 500 mg iron per vial Dosage: 500mg/week or 1000mg/week (based on subject Body Weight (BW) and Hb value at screening) Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline) Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15.	Iron Sucrose (IS) Participants treated with IS given by IV injection or drip infusion Dosage Form: Sterile solution for injection containing 2% w/v iron Strength: 5 mL ampoules containing 100 mg iron per ampoule Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit \[mg\] = BW \[kg\] x (target Hb- actual Hb) \[g/dL\] x 2.4 + 500 mg, up to 11 IS injections will be given Route of administration: IV injection or drip infusion Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose.
Overall Study Adverse Event	5	3
Overall Study Protocol Violation	2	1
Overall Study Withdrawal by Subject	0	5

Baseline Characteristics

To Assess the Impact of Ferric Carboxymaltose Compared With Iron Sucrose in Chinese Subjects on Correcting Iron Deficiency Anaemia

Baseline characteristics by cohort

Measure	Ferric Carboxymaltose (FCM) n=187 Participants Participants treated with FCM given by IV injection or drip infusion Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection Strength: 10 mL vials containing 500 mg iron per vial Dosage: 500mg/week or 1000mg/week (based on subject BW and Hb value at screening) Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline) Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15.	Iron Sucrose (IS) n=180 Participants Participants treated with IS given by IV injection or drip infusion Dosage Form: Sterile solution for injection containing 2% w/v iron Strength: 5 mL ampoules containing 100 mg iron per ampoule Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit \[mg\] = BW \[kg\] x (target Hb- actual Hb) \[g/dL\] x 2.4 + 500 mg, up to 11 IS injections will be given Route of administration: IV injection or drip infusion Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose.	Total n=367 Participants Total of all reporting groups
Age, Continuous	39.9 years STANDARD_DEVIATION 9.85 • n=5 Participants	38.9 years STANDARD_DEVIATION 8.70 • n=7 Participants	39.4 years STANDARD_DEVIATION 9.31 • n=5 Participants
Sex: Female, Male Female	173 Participants n=5 Participants	169 Participants n=7 Participants	342 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	187 Participants n=5 Participants	180 Participants n=7 Participants	367 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment China	187 Participants n=5 Participants	180 Participants n=7 Participants	367 Participants n=5 Participants
Haemoglobin	7.74 g/dl STANDARD_DEVIATION 1.491 • n=5 Participants	8.06 g/dl STANDARD_DEVIATION 1.453 • n=7 Participants	7.90 g/dl STANDARD_DEVIATION 1.479 • n=5 Participants
Serum ferritin	4.47 ng/ml STANDARD_DEVIATION 2.145 • n=5 Participants	4.93 ng/ml STANDARD_DEVIATION 6.095 • n=7 Participants	4.70 ng/ml STANDARD_DEVIATION 4.534 • n=5 Participants
Transferrin saturation (TSAT)	4.82 % STANDARD_DEVIATION 1.898 • n=5 Participants	4.92 % STANDARD_DEVIATION 2.912 • n=7 Participants	4.87 % STANDARD_DEVIATION 2.446 • n=5 Participants
High-sensitivity C-reactive protein (hsCRP)	1.026 mg/l STANDARD_DEVIATION 2.1432 • n=5 Participants	1.567 mg/l STANDARD_DEVIATION 5.9817 • n=7 Participants	1.291 mg/l STANDARD_DEVIATION 4.4617 • n=5 Participants

PRIMARY outcome

Timeframe: From baseline at any time up to Week 8

Population: Per Protocol Set: participants who were randomised, received at least 1 dose of study treatment, had at least 1 baseline and post-baseline value (Hb, ferritin, TSAT), had a study drug compliance between 80% and 120% and had no major protocol violations

Haemoglobin (Hb)

Outcome measures

Measure	Ferric Carboxymaltose (FCM) n=177 Participants Participants treated with FCM given by IV injection or drip infusion Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection Strength: 10 mL vials containing 500 mg iron per vial Dosage: 500mg/week or 1000mg/week (based on subject BW and Hb value at screening) Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline) Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15.	Iron Sucrose (IS) n=178 Participants Participants treated with IS given by IV injection or drip infusion Dosage Form: Sterile solution for injection containing 2% w/v iron Strength: 5 mL ampoules containing 100 mg iron per ampoule Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit \[mg\] = BW \[kg\] x (target Hb- actual Hb) \[g/dL\] x 2.4 + 500 mg, up to 11 IS injections will be given Route of administration: IV injection or drip infusion Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose.
Participants Achieving an Increase in Hb of at Least 2 g/dL at Any Time up to Week 8	176 Participants	175 Participants

SECONDARY outcome

Timeframe: From Baseline to weeks 2, 4, 6 and 8

Population: Per Protocol Set: participants who were randomised, received at least 1 dose of study treatment, had at least 1 baseline and post-baseline value (Hb, ferritin, TSAT), had a study drug compliance between 80% and 120% and had no major protocol violations

Haemoglobin (Hb)

Outcome measures

Measure	Ferric Carboxymaltose (FCM) n=177 Participants Participants treated with FCM given by IV injection or drip infusion Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection Strength: 10 mL vials containing 500 mg iron per vial Dosage: 500mg/week or 1000mg/week (based on subject BW and Hb value at screening) Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline) Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15.	Iron Sucrose (IS) n=178 Participants Participants treated with IS given by IV injection or drip infusion Dosage Form: Sterile solution for injection containing 2% w/v iron Strength: 5 mL ampoules containing 100 mg iron per ampoule Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit \[mg\] = BW \[kg\] x (target Hb- actual Hb) \[g/dL\] x 2.4 + 500 mg, up to 11 IS injections will be given Route of administration: IV injection or drip infusion Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose.
Participants Achieving an Increase in Hb of at Least 2 g/dL From Baseline to Weeks 2, 4, 6 and 8 Week 2	150 Participants	129 Participants
Participants Achieving an Increase in Hb of at Least 2 g/dL From Baseline to Weeks 2, 4, 6 and 8 Week 4	164 Participants	167 Participants
Participants Achieving an Increase in Hb of at Least 2 g/dL From Baseline to Weeks 2, 4, 6 and 8 Week 6	169 Participants	168 Participants
Participants Achieving an Increase in Hb of at Least 2 g/dL From Baseline to Weeks 2, 4, 6 and 8 Week 8	173 Participants	171 Participants

SECONDARY outcome

Timeframe: From Baseline to weeks 2, 4, 6 and 8

Population: Per Protocol Set: participants who were randomised, received at least 1 dose of study treatment, had at least 1 baseline and post-baseline value (Hb, ferritin, TSAT), had a study drug compliance between 80% and 120% and had no major protocol violations

Haemoglobin (Hb)

Outcome measures

Measure	Ferric Carboxymaltose (FCM) n=177 Participants Participants treated with FCM given by IV injection or drip infusion Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection Strength: 10 mL vials containing 500 mg iron per vial Dosage: 500mg/week or 1000mg/week (based on subject BW and Hb value at screening) Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline) Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15.	Iron Sucrose (IS) n=178 Participants Participants treated with IS given by IV injection or drip infusion Dosage Form: Sterile solution for injection containing 2% w/v iron Strength: 5 mL ampoules containing 100 mg iron per ampoule Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit \[mg\] = BW \[kg\] x (target Hb- actual Hb) \[g/dL\] x 2.4 + 500 mg, up to 11 IS injections will be given Route of administration: IV injection or drip infusion Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose.
Change in Hb From Baseline to Weeks 2, 4, 6, and 8 Week 2	3.01 g/dL Standard Deviation 1.135	2.53 g/dL Standard Deviation 1.016
Change in Hb From Baseline to Weeks 2, 4, 6, and 8 Week 4	4.46 g/dL Standard Deviation 1.502	4.08 g/dL Standard Deviation 1.217
Change in Hb From Baseline to Weeks 2, 4, 6, and 8 Week 6	4.96 g/dL Standard Deviation 1.435	4.61 g/dL Standard Deviation 1.422
Change in Hb From Baseline to Weeks 2, 4, 6, and 8 Week 8	5.09 g/dL Standard Deviation 1.504	4.87 g/dL Standard Deviation 1.525

SECONDARY outcome

Timeframe: From Baseline to Weeks 2, 4, 6 and 8

Population: Per Protocol Set: participants who were randomised, received at least 1 dose of study treatment, had at least 1 baseline and post-baseline value (Hb, ferritin, TSAT), had a study drug compliance between 80% and 120% and had no major protocol violations

Iron deficiency correction: TSAT >= 16% and serum ferritin >=100ng/mL (for subjects with underlying inflammatory disease) or >14ng/mL (for subjects with no apparent underlying inflammatory disease).

Outcome measures

Measure	Ferric Carboxymaltose (FCM) n=177 Participants Participants treated with FCM given by IV injection or drip infusion Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection Strength: 10 mL vials containing 500 mg iron per vial Dosage: 500mg/week or 1000mg/week (based on subject BW and Hb value at screening) Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline) Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15.	Iron Sucrose (IS) n=178 Participants Participants treated with IS given by IV injection or drip infusion Dosage Form: Sterile solution for injection containing 2% w/v iron Strength: 5 mL ampoules containing 100 mg iron per ampoule Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit \[mg\] = BW \[kg\] x (target Hb- actual Hb) \[g/dL\] x 2.4 + 500 mg, up to 11 IS injections will be given Route of administration: IV injection or drip infusion Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose.
Participants With Iron Deficiency Correction Over Time by Treatment Week 2	173 Participants	135 Participants
Participants With Iron Deficiency Correction Over Time by Treatment Week 4	165 Participants	168 Participants
Participants With Iron Deficiency Correction Over Time by Treatment Week 6	161 Participants	163 Participants
Participants With Iron Deficiency Correction Over Time by Treatment Week 8	162 Participants	154 Participants

SECONDARY outcome

Timeframe: From Baseline to weeks 2, 4, 6 and 8

Population: Per Protocol Set: participants who were randomised, received at least 1 dose of study treatment, had at least 1 baseline and post-baseline value (Hb, ferritin, TSAT), had a study drug compliance between 80% and 120% and had no major protocol violations

Transferrin saturation (TSAT)

Outcome measures

Measure	Ferric Carboxymaltose (FCM) n=177 Participants Participants treated with FCM given by IV injection or drip infusion Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection Strength: 10 mL vials containing 500 mg iron per vial Dosage: 500mg/week or 1000mg/week (based on subject BW and Hb value at screening) Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline) Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15.	Iron Sucrose (IS) n=178 Participants Participants treated with IS given by IV injection or drip infusion Dosage Form: Sterile solution for injection containing 2% w/v iron Strength: 5 mL ampoules containing 100 mg iron per ampoule Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit \[mg\] = BW \[kg\] x (target Hb- actual Hb) \[g/dL\] x 2.4 + 500 mg, up to 11 IS injections will be given Route of administration: IV injection or drip infusion Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose.
Change in TSAT From Baseline to Weeks 2, 4, 6 and 8 Week 2	30.16 Percentage of TSAT Standard Deviation 11.741	25.03 Percentage of TSAT Standard Deviation 19.474
Change in TSAT From Baseline to Weeks 2, 4, 6 and 8 Week 4	28.00 Percentage of TSAT Standard Deviation 8.528	25.30 Percentage of TSAT Standard Deviation 8.453
Change in TSAT From Baseline to Weeks 2, 4, 6 and 8 Week 6	25.50 Percentage of TSAT Standard Deviation 9.097	23.33 Percentage of TSAT Standard Deviation 7.868
Change in TSAT From Baseline to Weeks 2, 4, 6 and 8 Week 8	25.32 Percentage of TSAT Standard Deviation 10.793	20.82 Percentage of TSAT Standard Deviation 7.618

SECONDARY outcome

Timeframe: From Baseline to Weeks 2, 4, 6 and 8

Population: Per Protocol Set: participants who were randomised, received at least 1 dose of study treatment, had at least 1 baseline and post-baseline value (Hb, ferritin, TSAT), had a study drug compliance between 80% and 120% and had no major protocol violations

Outcome measures

Measure	Ferric Carboxymaltose (FCM) n=177 Participants Participants treated with FCM given by IV injection or drip infusion Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection Strength: 10 mL vials containing 500 mg iron per vial Dosage: 500mg/week or 1000mg/week (based on subject BW and Hb value at screening) Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline) Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15.	Iron Sucrose (IS) n=178 Participants Participants treated with IS given by IV injection or drip infusion Dosage Form: Sterile solution for injection containing 2% w/v iron Strength: 5 mL ampoules containing 100 mg iron per ampoule Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit \[mg\] = BW \[kg\] x (target Hb- actual Hb) \[g/dL\] x 2.4 + 500 mg, up to 11 IS injections will be given Route of administration: IV injection or drip infusion Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose.
Change in Serum Ferritin From Baseline to Weeks 2, 4, 6 and 8 Week 2	759.72 ng/ml Standard Deviation 331.118	385.51 ng/ml Standard Deviation 145.647
Change in Serum Ferritin From Baseline to Weeks 2, 4, 6 and 8 Week 4	379.31 ng/ml Standard Deviation 195.415	280.58 ng/ml Standard Deviation 148.913
Change in Serum Ferritin From Baseline to Weeks 2, 4, 6 and 8 Week 6	255.71 ng/ml Standard Deviation 152.582	184.93 ng/ml Standard Deviation 100.677
Change in Serum Ferritin From Baseline to Weeks 2, 4, 6 and 8 Week 8	202.09 ng/ml Standard Deviation 148.382	145.56 ng/ml Standard Deviation 89.890

SECONDARY outcome

Timeframe: From Baseline to weeks 2, 4, 6 and 8

Population: Safety Set: all randomised participants who have received at least 1 dose of study medication. The participants in this group were analysed based on the treatment they received.

Outcome measures

Measure	Ferric Carboxymaltose (FCM) n=187 Participants Participants treated with FCM given by IV injection or drip infusion Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection Strength: 10 mL vials containing 500 mg iron per vial Dosage: 500mg/week or 1000mg/week (based on subject BW and Hb value at screening) Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline) Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15.	Iron Sucrose (IS) n=180 Participants Participants treated with IS given by IV injection or drip infusion Dosage Form: Sterile solution for injection containing 2% w/v iron Strength: 5 mL ampoules containing 100 mg iron per ampoule Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit \[mg\] = BW \[kg\] x (target Hb- actual Hb) \[g/dL\] x 2.4 + 500 mg, up to 11 IS injections will be given Route of administration: IV injection or drip infusion Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose.
Change in Serum Iron From Baseline to Weeks 2, 4, 6 and 8 Week 2	15.53 umol/L Standard Deviation 7.075	16.23 umol/L Standard Deviation 14.512
Change in Serum Iron From Baseline to Weeks 2, 4, 6 and 8 Week 4	12.31 umol/L Standard Deviation 4.209	12.39 umol/L Standard Deviation 4.724
Change in Serum Iron From Baseline to Weeks 2, 4, 6 and 8 Week 6	10.77 umol/L Standard Deviation 4.318	11.27 umol/L Standard Deviation 4.160
Change in Serum Iron From Baseline to Weeks 2, 4, 6 and 8 Week 8	10.77 umol/L Standard Deviation 4.871	10.09 umol/L Standard Deviation 4.152

SECONDARY outcome

Timeframe: From Baseline to the End of the study (week 8)

Population: Safety Set: all randomised participants who have received at least 1 dose of study medication. The participants in this group were analysed based on the treatment they received.

Please note that in this section we are presenting just the overview of the adverse events experienced by the trial participant, in particular, the number of participants with at least one TEAE until end of the trial.

Please refer to the detailed tables included on the Adverse Event Module for specifics

Outcome measures

Measure	Ferric Carboxymaltose (FCM) n=187 Participants Participants treated with FCM given by IV injection or drip infusion Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection Strength: 10 mL vials containing 500 mg iron per vial Dosage: 500mg/week or 1000mg/week (based on subject BW and Hb value at screening) Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline) Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15.	Iron Sucrose (IS) n=180 Participants Participants treated with IS given by IV injection or drip infusion Dosage Form: Sterile solution for injection containing 2% w/v iron Strength: 5 mL ampoules containing 100 mg iron per ampoule Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit \[mg\] = BW \[kg\] x (target Hb- actual Hb) \[g/dL\] x 2.4 + 500 mg, up to 11 IS injections will be given Route of administration: IV injection or drip infusion Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose.
Participants With Any Treatment Emergent Adverse Event (TEAE)	124 Participants	101 Participants

SECONDARY outcome

Timeframe: Baseline and weeks 2, 4, 6 and 8

Population: Safety Set: all randomised participants who have received at least 1 dose of study medication. The participants in this group were analysed based on the treatment they received.

Diastolic Blood pressure

Outcome measures

Measure	Ferric Carboxymaltose (FCM) n=187 Participants Participants treated with FCM given by IV injection or drip infusion Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection Strength: 10 mL vials containing 500 mg iron per vial Dosage: 500mg/week or 1000mg/week (based on subject BW and Hb value at screening) Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline) Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15.	Iron Sucrose (IS) n=180 Participants Participants treated with IS given by IV injection or drip infusion Dosage Form: Sterile solution for injection containing 2% w/v iron Strength: 5 mL ampoules containing 100 mg iron per ampoule Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit \[mg\] = BW \[kg\] x (target Hb- actual Hb) \[g/dL\] x 2.4 + 500 mg, up to 11 IS injections will be given Route of administration: IV injection or drip infusion Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose.
Blood Pressure at Baseline and Weeks 2, 4, 6 and 8 Baseline	69.8 mmHg Standard Deviation 7.91	71.9 mmHg Standard Deviation 8.85
Blood Pressure at Baseline and Weeks 2, 4, 6 and 8 Week 2	71.0 mmHg Standard Deviation 8.33	72.6 mmHg Standard Deviation 8.79
Blood Pressure at Baseline and Weeks 2, 4, 6 and 8 Week 4	72.1 mmHg Standard Deviation 7.60	73.8 mmHg Standard Deviation 9.57
Blood Pressure at Baseline and Weeks 2, 4, 6 and 8 Week 6	71.6 mmHg Standard Deviation 8.18	74.3 mmHg Standard Deviation 9.24
Blood Pressure at Baseline and Weeks 2, 4, 6 and 8 Week 8	72.4 mmHg Standard Deviation 8.09	74.1 mmHg Standard Deviation 9.77

SECONDARY outcome

Timeframe: Baseline and week 8

Population: Safety Set: all randomised participants who have received at least 1 dose of study medication. The participants in this group were analysed based on the treatment they received.

Outcome measures

Measure	Ferric Carboxymaltose (FCM) n=187 Participants Participants treated with FCM given by IV injection or drip infusion Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection Strength: 10 mL vials containing 500 mg iron per vial Dosage: 500mg/week or 1000mg/week (based on subject BW and Hb value at screening) Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline) Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15.	Iron Sucrose (IS) n=180 Participants Participants treated with IS given by IV injection or drip infusion Dosage Form: Sterile solution for injection containing 2% w/v iron Strength: 5 mL ampoules containing 100 mg iron per ampoule Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit \[mg\] = BW \[kg\] x (target Hb- actual Hb) \[g/dL\] x 2.4 + 500 mg, up to 11 IS injections will be given Route of administration: IV injection or drip infusion Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose.
Body Weight at Baseline and Week 8 Baseline	59.76 kg Standard Deviation 9.384	60.40 kg Standard Deviation 9.354
Body Weight at Baseline and Week 8 Week 8	59.73 kg Standard Deviation 9.316	60.64 kg Standard Deviation 9.372

SECONDARY outcome

Timeframe: Baseline and weeks 2, 4, 6 and 8

Population: Safety Set: all randomised participants who have received at least 1 dose of study medication. The participants in this group were analysed based on the treatment they received.

Outcome measures

Measure	Ferric Carboxymaltose (FCM) n=187 Participants Participants treated with FCM given by IV injection or drip infusion Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection Strength: 10 mL vials containing 500 mg iron per vial Dosage: 500mg/week or 1000mg/week (based on subject BW and Hb value at screening) Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline) Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15.	Iron Sucrose (IS) n=180 Participants Participants treated with IS given by IV injection or drip infusion Dosage Form: Sterile solution for injection containing 2% w/v iron Strength: 5 mL ampoules containing 100 mg iron per ampoule Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit \[mg\] = BW \[kg\] x (target Hb- actual Hb) \[g/dL\] x 2.4 + 500 mg, up to 11 IS injections will be given Route of administration: IV injection or drip infusion Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose.
Heart Rate at Baseline and Weeks 2, 4, 6 and 8 Baseline	81.4 beats/min Standard Deviation 8.85	82.2 beats/min Standard Deviation 9.94
Heart Rate at Baseline and Weeks 2, 4, 6 and 8 Week 2	76.3 beats/min Standard Deviation 9.80	76.5 beats/min Standard Deviation 8.83
Heart Rate at Baseline and Weeks 2, 4, 6 and 8 Week 4	75.5 beats/min Standard Deviation 10.71	76.6 beats/min Standard Deviation 10.79
Heart Rate at Baseline and Weeks 2, 4, 6 and 8 Week 6	76.0 beats/min Standard Deviation 8.98	77.2 beats/min Standard Deviation 10.04
Heart Rate at Baseline and Weeks 2, 4, 6 and 8 Week 8	75.8 beats/min Standard Deviation 10.33	77.5 beats/min Standard Deviation 10.94

SECONDARY outcome

Timeframe: Baseline and weeks 2, 4, 6 and 8

Population: Safety Set: all randomised participants who have received at least 1 dose of study medication. The participants in this group were analysed based on the treatment they received.

Outcome measures

Measure	Ferric Carboxymaltose (FCM) n=187 Participants Participants treated with FCM given by IV injection or drip infusion Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection Strength: 10 mL vials containing 500 mg iron per vial Dosage: 500mg/week or 1000mg/week (based on subject BW and Hb value at screening) Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline) Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15.	Iron Sucrose (IS) n=180 Participants Participants treated with IS given by IV injection or drip infusion Dosage Form: Sterile solution for injection containing 2% w/v iron Strength: 5 mL ampoules containing 100 mg iron per ampoule Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit \[mg\] = BW \[kg\] x (target Hb- actual Hb) \[g/dL\] x 2.4 + 500 mg, up to 11 IS injections will be given Route of administration: IV injection or drip infusion Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose.
Body Temperature at Baseline and Weeks 2, 4, 6 and 8 Baseline	36.94 ºC Standard Deviation 0.292	36.45 ºC Standard Deviation 0.325
Body Temperature at Baseline and Weeks 2, 4, 6 and 8 Week 2	36.48 ºC Standard Deviation 0.269	36.44 ºC Standard Deviation 0.288
Body Temperature at Baseline and Weeks 2, 4, 6 and 8 Week 4	36.49 ºC Standard Deviation 0.269	36.40 ºC Standard Deviation 0.268
Body Temperature at Baseline and Weeks 2, 4, 6 and 8 Week 6	36.47 ºC Standard Deviation 0.259	36.41 ºC Standard Deviation 0.260
Body Temperature at Baseline and Weeks 2, 4, 6 and 8 Week 8	36.48 ºC Standard Deviation 0.269	36.46 ºC Standard Deviation 0.257

Adverse Events

Ferric Carboxymaltose (FCM)

Serious events: 10 serious events

Other events: 124 other events

Deaths: 0 deaths

Iron Sucrose (IS)

Serious events: 7 serious events

Other events: 92 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ferric Carboxymaltose (FCM) n=187 participants at risk Participants treated with FCM given by IV injection or drip infusion Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection Strength: 10 mL vials containing 500 mg iron per vial Dosage: 500mg/week or 1000mg/week (based on subject BW and Hb value at screening) Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline) Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15.	Iron Sucrose (IS) n=180 participants at risk Participants treated with IS given by IV injection or drip infusion Dosage Form: Sterile solution for injection containing 2% w/v iron Strength: 5 mL ampoules containing 100 mg iron per ampoule Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit \[mg\] = BW \[kg\] x (target Hb- actual Hb) \[g/dL\] x 2.4 + 500 mg, up to 11 IS injections will be given Route of administration: IV injection or drip infusion Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.53% 1/187 • Number of events 1 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	0.00% 0/180 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.53% 1/187 • Number of events 1 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	0.00% 0/180 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.53% 1/187 • Number of events 1 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	0.00% 0/180 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Gastrointestinal disorders Crohn's disease	0.53% 1/187 • Number of events 1 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	1.1% 2/180 • Number of events 2 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Gastrointestinal disorders Abdominal pain	0.53% 1/187 • Number of events 1 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	0.00% 0/180 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Gastrointestinal disorders Abdominal adhesions	0.00% 0/187 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	0.56% 1/180 • Number of events 1 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Reproductive system and breast disorders Uterine polyp	0.53% 1/187 • Number of events 1 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	0.00% 0/180 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Reproductive system and breast disorders Menorrhagia	0.00% 0/187 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	1.1% 2/180 • Number of events 2 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Reproductive system and breast disorders Adenomyosis	0.00% 0/187 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	0.56% 1/180 • Number of events 1 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Reproductive system and breast disorders Pelvic adhesions	0.00% 0/187 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	0.56% 1/180 • Number of events 1 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Immune system disorders Anaphylactic reaction	0.53% 1/187 • Number of events 1 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	0.00% 0/180 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Immune system disorders Anaphylactic shock	0.00% 0/187 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	0.56% 1/180 • Number of events 1 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Infections and infestations Anal abscess	0.53% 1/187 • Number of events 1 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	0.00% 0/180 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Infections and infestations Urinary tract infection	0.00% 0/187 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	0.56% 1/180 • Number of events 1 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Hepatobiliary disorders Cholecystitis acute	0.53% 1/187 • Number of events 1 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	0.00% 0/180 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Surgical and medical procedures Abortion induced	0.53% 1/187 • Number of events 1 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	0.00% 0/180 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
General disorders Pyrexia	0.00% 0/187 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	0.56% 1/180 • Number of events 1 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.

Other adverse events

Measure	Ferric Carboxymaltose (FCM) n=187 participants at risk Participants treated with FCM given by IV injection or drip infusion Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection Strength: 10 mL vials containing 500 mg iron per vial Dosage: 500mg/week or 1000mg/week (based on subject BW and Hb value at screening) Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline) Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15.	Iron Sucrose (IS) n=180 participants at risk Participants treated with IS given by IV injection or drip infusion Dosage Form: Sterile solution for injection containing 2% w/v iron Strength: 5 mL ampoules containing 100 mg iron per ampoule Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit \[mg\] = BW \[kg\] x (target Hb- actual Hb) \[g/dL\] x 2.4 + 500 mg, up to 11 IS injections will be given Route of administration: IV injection or drip infusion Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose.
Investigations Urine phosphorus decreased	7.5% 14/187 • Number of events 18 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	7.8% 14/180 • Number of events 16 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Investigations Blood phosphorus decreased	7.0% 13/187 • Number of events 13 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	0.56% 1/180 • Number of events 1 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Investigations Alanine aminotransferase increased	5.9% 11/187 • Number of events 14 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	2.8% 5/180 • Number of events 6 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Investigations White blood cells urine positive	3.7% 7/187 • Number of events 7 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	4.4% 8/180 • Number of events 8 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Investigations Aspartate aminotransferase increased	3.7% 7/187 • Number of events 7 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	2.2% 4/180 • Number of events 4 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Investigations Gamma-glutamyl transferase increased	3.2% 6/187 • Number of events 6 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	3.3% 6/180 • Number of events 6 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Investigations Hepatic enzyme increased	3.2% 6/187 • Number of events 7 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	1.7% 3/180 • Number of events 3 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Investigations Red blood cells urine positive	2.1% 4/187 • Number of events 4 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	0.56% 1/180 • Number of events 1 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Infections and infestations Upper respiratory tract infection	8.0% 15/187 • Number of events 17 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	7.2% 13/180 • Number of events 13 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Infections and infestations Urinary tract infection	3.2% 6/187 • Number of events 6 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	3.9% 7/180 • Number of events 7 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Metabolism and nutrition disorders Hypophosphataemia	10.2% 19/187 • Number of events 20 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	2.8% 5/180 • Number of events 5 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Gastrointestinal disorders Nausea	2.7% 5/187 • Number of events 6 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	1.1% 2/180 • Number of events 3 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Gastrointestinal disorders Abdominal pain upper	2.1% 4/187 • Number of events 4 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	0.00% 0/180 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Gastrointestinal disorders Crohn's disease	1.1% 2/187 • Number of events 2 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	2.2% 4/180 • Number of events 4 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
General disorders Pyrexia	6.4% 12/187 • Number of events 12 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	1.7% 3/180 • Number of events 3 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Hepatobiliary disorders Hepatic function abnormal	7.0% 13/187 • Number of events 16 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	5.0% 9/180 • Number of events 12 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Skin and subcutaneous tissue disorders Rash	2.1% 4/187 • Number of events 4 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	0.56% 1/180 • Number of events 1 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Skin and subcutaneous tissue disorders Urticaria	2.1% 4/187 • Number of events 4 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	0.00% 0/180 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Reproductive system and breast disorders Menorrhagia	1.1% 2/187 • Number of events 2 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	3.3% 6/180 • Number of events 6 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.
Nervous system disorders Headache	2.1% 4/187 • Number of events 4 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.	0.00% 0/180 • From Baseline until the End of the Study (8 weeks) All AEs either observed by the Investigator/collaborators, or reported by the subject spontaneously, or in response to a direct question, were noted in the AE section of the case report form/source document. In order to avoid bias in eliciting AEs, subjects were asked a non-leading question, such as "How are you feeling?" A non-leading question was used as well for changes in their health or concomitant medication usage since their last visit. This information was collected at all study visits.

Additional Information

VIT-IRON-2011-004 Clinical Study Team

Vifor (International) Inc.

Phone: +41 58 851 80 00

Email: VIT-IRON-2011-004.study@viforpharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place